Japan Drug Approvals
Japan has its own drug regulator, PMDA, and drugs often reach Japanese patients years after American ones, which Japan calls drug lag. This is every drug Japan approved since 2008, matched to when the US approved the same medicine.
2,166 approvals from Japan's drug regulator (PMDA), April 2008 to Feb 19, 2026, 727 of them new active ingredients. Each new ingredient is matched to its first US approval, so you can see how far Japan runs behind or ahead.
- Approvals in the last 12 months: 148
- New ingredients, last 12 months: 47
- Approved in the US first, last 5 years: 57%
- Median lag when US first: 26 months
- Newest in PMDA's list: Feb 19, 2026
New Active Ingredients per Year
Approved in Japan, 2009 to Feb 19, 2026.
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
- Full year
- 2026 to date
Months Behind the US
Median, for new ingredients the US approved first, by year of Japanese approval.
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
- Full year
- 2026 to date
New Ingredients by Area
PMDA review category, 2022 to 2026.
- Cancer63
- Gastrointestinal, skin and immune27
- Heart, Parkinson's and Alzheimer's26
- Hormones and metabolism23
- Vaccines22
- Respiratory and allergy21
- Nervous system18
- Infections15
- Blood products10
- Reproductive and urinary6
- Anesthesia, eye and narcotics6
- Radiopharmaceuticals5
- HIV2
Newest Approvals
The last two years; new approvals, new ingredients and changes such as a new indication.| Feb 19, 2026 | KyinsuInsulin Icodec (genetical recombination)/ Semaglutide (genetical recombination) | Novo Nordisk Pharma Ltd. | New approval | A new combination drug indicated for the treatment of type 2 diabetes mellitus in cases where insulin therapy is indicated. |
| Feb 19, 2026 | SohonosPalovarotene | IPSEN Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of fibrodysplasia ossificans progressiva. [Orphan drug] |
| Feb 19, 2026 | AquiptaAtogepant hydrate | AbbVie GK | New ingredient | Drugs with a new active ingredient indicated for the prevention of migraine attacks. |
| Feb 19, 2026 | TezspireTezepelumab (genetical recombination) | AstraZeneca K.K. | Change | Drugs with a new indication and a new dosage for the treatment of chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments). |
| Feb 19, 2026 | SaphneloAnifrolumab (genetical recombination) | AstraZeneca K.K. | New approval | A drug with a new route of administration indicated for the treatment of systemic lupus erythematosus in patients who have not responded sufficiently to conventional treatments. |
| Feb 19, 2026 | IlarisCanakinumab (genetical recombination) | Novartis Pharma K.K. | Change | A drug with a new indication and a new dosage for the treatment of Schnitzler syndrome. [Orphan drug] |
| Feb 19, 2026 | TukysaTucatinib ethanolate | Pfizer Japan Inc. | New ingredient | Drugs with a new active ingredient indicated for the treatment of human epidermal growth factor receptor 2 (HER2)-positive inoperable or recurrent breast cancer in patients who have previously been treated with chemotherapy. |
| Feb 19, 2026 | VonvendiVonicog alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Change | A drug with a new additional pediatric dosage indicated for the control of bleeding tendency in patients with von Willebrand disease (VWD). [Orphan drug] |
| Feb 19, 2026 | Parmodia XRPemafibrate | Kowa Company, Ltd. | Change | Drugs with a new dosage indicated for the treatment of hyperlipidemia (including familial hyperlipidemia). |
| Feb 19, 2026 | TremfyaGuselkumab (genetical recombination) | Janssen Pharmaceutical K.K. | Change | Drugs with a new indication and a new dosage for the remission induction therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). |
| Feb 19, 2026 | RituxanRituximab (genetical recombination) | Zenyaku Kogyo Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of autoimmune hemolytic anemia. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Feb 19, 2026 | DiagnogreenIndocyanine green | Daiichi Sankyo Company, Limited | Change | A drug with a new route of administration, new indications, and new dosages for the sentinel lymph node mapping in cervical and endometrial cancer and evaluation of lymphatic flow related to lymphaticovenular anastomosis. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Feb 19, 2026 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the preoperative and postoperative adjuvant treatment for locally advanced head and neck cancer. |
| Feb 19, 2026 | BesremiRopeginterferon alfa-2a (genetical recombination) | PharmaEssence Japan K.K. | Change | Drugs with a new dosage indicated for the treatment of polycythaemia vera (use only when conventional therapies are not sufficiently effective or inappropriate). |
| Feb 19, 2026 | MekinistTrametinib dimethyl sulfoxide | Novartis Pharma K.K. | Change | Drugs with a new indication and a new dosage for the treatment of low-grade serous ovarian cancer that has progressed after cancer chemotherapy. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Dec 22, 2025 | RybrofazAmivantamab (genetical recombination)/ Vorhyaluronidase alfa (genetical recombination) | Janssen Pharmaceutical K.K. | New approval | A new combination drug indicated for the treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene exon 20 insertion mutation-positive non-small cell lung cancer and unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene mutation-positive non- small cell lung cancer. |
| Dec 22, 2025 | ZurzuvaeZuranolone | Shionogi & Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of depression. |
| Dec 22, 2025 | LunsumioMosunetuzumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | New approval | Drugs with a new route of administration indicated for the treatment of relapsed or refractory follicular lymphoma. |
| Dec 22, 2025 | Upneeq MiniOxymetazoline hydrochloride | Santen Pharmaceutical Co., Ltd. | New approval | A drug with a new indication and a new dosage in an additional dosage form for the treatment of acquired blepharoptosis. |
| Dec 22, 2025 | SephienceSepiapterin | PTC Therapeutics K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of phenylketonuria. [Orphan drug] |
| Dec 22, 2025 | RavictiGlycerol phenylbutyrate | OrphanPacific, Inc. | New ingredient | A drug with a new active ingredient indicated for the treatment of urea cycle disorders. [Orphan drug] |
| Dec 22, 2025 | PreemieFort(1) (2) Human milk/ Calcium glycerophosphate/ Calcium gluconate hydrate/Calcium chloride hydrate/Anhydrous Sodium Citrate/Potassium citrate/Magnesium monohydrogen phosphate/Zinc sulfate hydrate/Sodium chloride/Copper sulfate (3) Human milk | Clinigen K.K. | New ingredient | (1) (2) New combination drugs with a new active ingredient indicated for the nutritional management of neonates and infants with failure to thrive, such as very low birth weight infants. (3) A drug with a new active ingredient indicated for the nutritional management of neonates and infants with failure to thrive, such as very low birth weight infants. |
| Dec 22, 2025 | YseltyLinzagolix choline | Kissei Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the alleviation of menorrhagia, lower abdominal pain, backache, and anemia that are associated with uterine fibroids. |
| Dec 22, 2025 | KerendiaFinerenone | Bayer Yakuhin, Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of chronic heart failure (for use only in patients receiving standard treatment of chronic heart failure). |
| Dec 22, 2025 | OpsumitMacitentan | Janssen Pharmaceutical K.K. | New approval | (1) (2) Drugs with a new pediatric dosage in additional dosage forms indicated for the treatment of pulmonary arterial hypertension. (3) A drug with a new additional pediatric dosage indicated for the treatment of pulmonary arterial hypertension. [Orphan drug] [Drugs for specific use] |
| Dec 22, 2025 | InluriyoImlunestrant tosilate | Eli Lilly Japan K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2 )-negative inoperable or recurrent breast cancer with ESR1 mutation that has progressed after endocrine therapy. |
| Dec 22, 2025 | ZynyzRetifanlimab (genetical recombination) | Incyte Biosciences Japan G.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent squamous cell carcinoma of the anal canal. [Orphan drug] |
| Dec 22, 2025 | ElzonrisTagraxofusp (genetical recombination) | Nippon Shinyaku Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm. [Orphan drug] |
| Dec 22, 2025 | MinjuviTafasitamab (genetical recombination) | Incyte Biosciences Japan G.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of relapsed or refractory follicular lymphoma. [Orphan drug] |
| Dec 22, 2025 | TecentriqAtezolizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | A drug with a new indication and a new dosage for the treatment of unresectable thymic carcinoma. [Orphan drug] |
| Dec 22, 2025 | ExdensurDepemokimab (genetical recombination) | GlaxoSmithKline K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of bronchial asthma (for use only in patients with severe or intractable bronchial asthma whose asthmatic responses are uncontrollable with conventional therapies) and chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments). |
| Dec 22, 2025 | EkterlySebetralstat | KalVista Pharmaceuticals Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of acute attacks of hereditary angioedema. [Orphan drug] |
| Dec 22, 2025 | AvareptMotugivatrep | Senju Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of dry eye. |
| Dec 22, 2025 | DupixentDupilumab (genetical recombination) | Sanofi K.K. | Change | Drugs with a new additional pediatric dosage indicated for the treatment of bronchial asthma (for use only in patients with severe or intractable bronchial asthma whose asthmatic responses are uncontrollable with conventional therapies). |
| Dec 22, 2025 | AdzynmaApadamtase alfa (genetical recombination)/ Cinaxadamtase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Change | A drug with a new additional pediatric dosage indicated for the treatment of congenital thrombotic thrombocytopenic purpura. [Orphan drug] |
| Dec 22, 2025 | CarboplatinCarboplatin | Viatris Healthcare G.K. | Change | Drugs with a new route of administration indicated for the treatment of ovarian cancer. |
| Dec 22, 2025 | Ustekinumab BSUstekinumab (genetical recombination) [Ustekinumab biosimilar 4] | Nipro Corporation | New approval | A biosimilar indicated for the treatment of the following diseases in patients who have not sufficiently responded to conventional therapies: plaque psoriasis and psoriatic arthritis |
| Nov 20, 2025 | UpliznaInebilizumab (genetical recombination) | Tanabe Pharma Corporation | Change | A drug with a new indication for the prevention of relapse of IgG4 related disease. [Orphan drug] |
| Nov 20, 2025 | BraftoviEncorafenib | Ono Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable, advanced or recurrent BRAF mutation-positive colorectal cancer. [Orphan drug] |
| Nov 20, 2025 | AugtyroRepotrectinib | Bristol-Myers Squibb K.K. | Change | Drugs with a new indication and a new dosage for the treatment of NTRK fusion gene-positive advanced or recurrent solid tumors. [Orphan drug] |
| Nov 20, 2025 | BeovuBrolucizumab (genetical recombination) | Novartis Pharma K.K. | Change | A drug with a new indication and a new dosage for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization and proliferative diabetic retinopathy. |
| Nov 20, 2025 | VenclextaVenetoclax | AbbVie GK | Change | Drugs with a new indication and a new dosage for the treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma). |
| Nov 20, 2025 | DarzquroDaratumumab (genetical recombination)/ Vorhyaluronidase alfa (genetical recombination) | Janssen Pharmaceutical K.K. | Change | A drug with a new indication and a new dosage for delaying the progression of high-risk smoldering multiple myeloma. |
| Nov 20, 2025 | AnaemetroMetronidazole | Pfizer Japan Inc. | Change | A drug with a new additional pediatric dosage indicated for the treatment of anaerobic infection (sepsis, deep skin infection, secondary infections of traumas/burns and surgical wounds, osteomyelitis, pneumonia, lung abscess, empyema, pelvic inflammatory disease, peritonitis, intra-abdominal abscess, cholecystitis, liver abscess, purulent meningitis, and brain abscess caused by Metronidazole-sensitive Peptostreptococcus spp., Bacteroides spp., Prevotella spp., Porphyromonas spp., Fusobacterium spp., Clostridium spp., and Eubacterium spp.), infectious e nteritis (Infectious enteritis [including pseudomembranous colitis] caused by Metronidazole-sensitive Clostridium difficile ), and amoebic dysentery. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Sep 19, 2025 | NexletolBempedoic acid | Otsuka Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of hypercholesterolemia and familial hypercholesterolemia. |
| Sep 19, 2025 | Nurtec ODRimegepant sulfate hydrate | Pfizer Japan Inc. | New ingredient | A drug with a new active ingredient indicated for the acute treatment and prevention of migraine attacks. |
| Sep 19, 2025 | Ycanth TopicalCantharidin | Torii Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of molluscum contagiosum. |
| Sep 19, 2025 | BylvayOdevixibat hydrate | Ipsen Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis. [Orphan drug] |
| Sep 19, 2025 | Fujichenon GranularChenodeoxycholic acid | Fujimoto Pharmaceutical Corporation | New approval | A drug with a new indication and a new dosage in an additional dosage form for the treatment of cerebrotendinous xanthomatosis. [Orphan drug] |
| Sep 19, 2025 | ImaavyNipocalimab (genetical recombination) | Janssen Pharmaceutical K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of generalized myasthenia gravis (for use only in patients who have not sufficiently responded to steroids or other immunosuppressants). [Orphan drug] |
| Sep 19, 2025 | IzervayAvacincaptad pegol sodium | Astellas Pharma Inc. | New ingredient | A drug with a new active ingredient indicated for slowing the progression of geographic atrophy secondary to age-related macular degeneration. [Conditional approval] |
| Sep 19, 2025 | DormicumMidazolam | Maruishi Pharmaceutical Co., Ltd. | New approval | A drug with a new route of administration indicated for anesthetic premedication. [Drugs for specific use] |
| Sep 19, 2025 | XofluzaBaloxavir marboxil | Shionogi & Co., Ltd. | Change | A drug with a new additional pediatric dosage indicated for the treatment of influenza A or B virus infection. |
| Sep 19, 2025 | NeffyAdrenaline | Alfresa Pharma Corporation | New approval | Drugs with a new route of administration indicated for the adjunctive treatment for anaphylactic reactions caused by bee venom, foods, drugs, and others (for use only in individuals with a history of anaphylaxis or at a high risk of anaphylaxis). |
| Sep 19, 2025 | TecentriqAtezolizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma, nasal type. |
| Sep 19, 2025 | VoranigoVorasidenib citric acid hydrate | Nihon Servier Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of IDH1 or IDH2 gene mutation-positive glioma. [Orphan drug] |
| Sep 19, 2025 | HernexeosZongertinib | Nippon Boehringer Ingelheim Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent HER2 (ERBB2 ) mutation-positive non-small cell lung cancer that has progressed after cancer chemotherapy. [Orphan drug] |
| Sep 19, 2025 | IbtroziTaletrectinib adipate | Nippon Kayaku Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of ROS1 fusion gene-positive unresectable advanced or recurrent non-small-cell lung cancer. [Orphan drug] |
| Sep 19, 2025 | Pluvicto177 Lu) tetraxetan | Novartis Pharma K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of PSMA-positive, metastatic castration- resistant prostate cancer. |
| Sep 19, 2025 | LocametzGozetotide | Novartis Pharma K.K. | New ingredient | A drug with a new active ingredient indicated for the support of selection of patients with prostate cancer, for whom PSMA-targeted therapy is indicated. |
| Sep 19, 2025 | 6868 Ga) chloride | Not listed | New ingredient | A drug with a new active ingredient indicated for gallium 68 ( Ga) radiolabelling of radiopharmaceutical precursors approved for positron emission tomography (PET) imaging. |
| Sep 19, 2025 | Aflibercept BSAflibercept (genetical recombination) [aflibercept biosimilar 2] | Fuji Pharma Co., Ltd. | New approval | Biosimilars indicated for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization, macular edema following retinal vein occlusion, and choroidal neovascularization in patients with pathologic myopia. |
| Sep 19, 2025 | Aflibercept BSAflibercept (genetical recombination) [aflibercept biosimilar 3] | SamChunDang Pharm. Co., Ltd. | New approval | Biosimilars indicated for the treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization, macular edema following retinal vein occlusion, and choroidal neovascularization in patients with pathologic myopia. |
| Sep 19, 2025 | KoselugoSelmetinib sulfate | Alexion Pharma GK | New approval | (1) (2) Drugs with a new dosage in an additional dosage form indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1. (3) (4) Drugs with a new dosage indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1. [Orphan drug] |
| Sep 19, 2025 | Spinraza IntrathecalNusinersen sodium | Biogen Japan Ltd. | New approval | Drugs with a new dosage in an additional dosage form indicated for the treatment of spinal muscular atrophy. [Orphan drug] |
| Sep 19, 2025 | CellceptMycophenolate mofetil | [1] [2] Chugai Pharmaceutical Co., Ltd., [3] Viatris Healthcare G.K. | Change | Drugs with a new indication and a new dosage for the treatment of refractory nephrotic syndrome (for use frequent relapsing or steroid-dependent nephrotic syndrome). [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Sep 19, 2025 | LibtayoCemiplimab (genetical recombination) | Regeneron Japan KK | Change | A drug with a new indication for the treatment of unresectable advanced or recurrent non-small-cell lung cancer. |
| Sep 19, 2025 | Denosumab BSDenosumab (genetical recombination) [denosumab biosimilar 1] | Fuji Pharma Co., Ltd. | New approval | A biosimilar indicated for the treatment of bone lesions due to multiple myeloma and bone metastasis of solid tumor. |
| Sep 19, 2025 | ImfinziDurvalumab (genetical recombination) | AstraZeneca K.K. | Change | Drugs with a new indication and a new dosage for the preoperative and postoperative adjuvant treatment for non-small cell lung cancer and preoperative and postoperative adjuvant treatment for bladder cancer. |
| Sep 19, 2025 | Tocilizumab BSTocilizumab (genetical recombination) [tocilizumab biosimilar 1] | Celltrion Healthcare Japan K.K. | New approval | (1) (2) (3) Biosimilars indicated for the following diseases: ・The treatment of rheumatoid arthritis (including the prevention of structural joint damage), polyarticular- course juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, in patients who have not sufficiently responded to conventional treatments. ・The improvement of various symptoms and laboratory findings associated with Castleman's disease for whom resection of lymph nodes is not indicated. ・The treatment of cytokine release syndrome induced by the treatment of malignant tumor. (4) (5) Biosimilars indicated for the following disease： ・The treatment of rheumatoid arthritis (including the prevention of structural joint damage) in patients who have not sufficiently responded to conventional treatments. |
| Sep 19, 2025 | JiviDamoctocog alfa pegol (genetical recombination) | Bayer Yakuhin, Ltd. | Change | Drugs with a new additional pediatric dosage indicated for the control of bleeding tendency in patients with blood coagulation factor VIII deficiency. |
| Sep 19, 2025 | TecentriqAtezolizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | Drugs with a new dosage indicated for the treatment of following diseases: ・Unresectable advanced or recurrent non-small cell lung cancer ・Postoperative adjuvant treatment for PD-L1 positive non-small cell lung cancer ・PD-L1 positive, hormone receptor (HR)-negative, and human epidermal growth factor receptor 2 (HER2)- negative inoperable or recurrent breast cancer ・Extensive-stage small-cell lung cancer |
| Sep 19, 2025 | LumakrasSotorasib | Amgen K.K. | Change | A drug with a new indication and a new dosage for the treatment of unresectable advanced or recurrent KRAS G12C mutation-positive colorectal cancer that has progressed after cancer chemotherapy. |
| Sep 19, 2025 | VectibixPanitumumab (genetical recombination) | Takeda Pharmaceutical Company Limited | Change | Drugs with a new indication and a new dosage for the treatment of unresectable advanced or recurrent KRAS G12C mutation-positive colorectal cancer that has progressed after cancer chemotherapy. |
| Sep 19, 2025 | JaypircaPirtobrutinib | Eli Lilly Japan K.K. | Change | Drugs with a new indication for the treatment of relapsed or refractory chronic lymphocytic leukemia (including small lymphocytic lymphoma) with resistant or intolerant to other BTK inhibitors. |
| Sep 19, 2025 | Raiatt MIBG-I3-Iodobenzylguanidine 131 ( I) | PDRadiopharma Inc. | Change | A drug with a new indication and a new dosage for the treatment of MIBG-positive neuroblastoma. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs Council] |
| Sep 19, 2025 | Golimumab BSGolimumab (genetical recombination) [golimumab biosimilar 1] | Fuji Pharma Co., Ltd. | New approval | A biosimilar indicated for the treatment of rheumatoid arthritis (including the prevention of structural joint damage) in patients who have not sufficiently responded to conventional treatments. |
| Aug 25, 2025 | DopteletAvatrombopag maleate | Swedish Orphan Biovitrum Japan Co., Ltd. | Change | A drug with a new indication and a new dosage for the treatment of persistent and chronic immune thrombocytopenia. |
| Aug 25, 2025 | VorzzzVornorexant hydrate | Taisho Pharmaceutical Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of insomnia. |
| Aug 25, 2025 | SetaneoSepetaprost | Santen Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of glaucoma and ocular hypertension. |
| Aug 25, 2025 | MagmittMagnesium oxide | Magmitt Pharmaceutical Co., Ltd. | New approval | (1) A drug with a new pediatric dosage in an additional dosage form indicated for the treatment of constipation. (2) (3) (4) (5) (6) Drugs with a new pediatric dosage indicated for the treatment of constipation. |
| Aug 25, 2025 | YorvipathPalopegteriparatide | Teijin Pharma Limited | New ingredient | Drugs with a new active ingredient indicated for the treatment of hypoparathyroidism. [Orphan drug] |
| Aug 25, 2025 | OpdivoNivolumab (genetical recombination) | Ono Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and new dosage for the treatment of unresectable, advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer. [Orphan drug] |
| Aug 25, 2025 | YervoyIpilimumab (genetical recombination) | Bristol-Myers Squibb K.K. | Change | Drugs with a new indication and new dosage for the treatment of unresectable, advanced or recurrent microsatellite instability-high (MSI-High) colorectal cancer. [Orphan drug] |
| Aug 25, 2025 | KoselugoSelmetinib sulfate | Alexion Pharma GK | Change | Drugs with a new dosage indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1. [Orphan drug] |
| Aug 25, 2025 | KisunlaDonanemab (genetical recombination) | Eli Lilly Japan K.K. | Change | A drug with a new dosage indicated for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease. |
| Aug 25, 2025 | EnhertuTrastuzumab deruxtecan (genetical recombination) | Daiichi Sankyo Company, Limited | Change | A drug with a new indication for the treatment of hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-low or -ultralow inoperable or recurrent breast cancer. |
| Aug 25, 2025 | SilgardRecombinant adsorbed 9-valent human papillomavirus virus-like particle vaccines (yeast origin) | MSD K.K. | Change | A drug with a new indication for the prevention of the following diseases caused by infection with human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52, and 58: ・Anal cancer (squamous cell carcinoma) and its precursor lesions (anal intraepithelial neoplasia [AIN] 1, 2, and 3) |
| Aug 25, 2025 | CalquenceAcalabrutinib maleate hydrate | AstraZeneca K.K. | Change | A drug with a new indication and a new dosage for the treatment of mantle cell lymphoma. |
| Aug 8, 2025 | CapvaxivePneumococcal 21- valent conjugate vaccine (mutated diphtheria CRM197 conjugate) | MSD K.K. | New ingredient | A drug with a new active ingredient indicated for the prophylaxis of pneumococcal disease in the elderly or in adults who are considered to be at a high risk of pneumococcal disease. |
| Jun 24, 2025 | AneremRemimazolam besilate | Mundipharma K.K. | New approval | (1) A drug with a new indication and a new dosage in an additional dosage form for sedation during gastrointestinal endoscopy. (2) A drug with a new indication, a new dosage, and other characteristics for sedation during gastrointestinal endoscopy. |
| Jun 24, 2025 | XeominIncobotulinumtoxin A | Teijin Pharma Limited | Change | Drugs with a new route of administration indicated for the treatment of chronic sialorrhea. |
| Jun 24, 2025 | HyQviapH4-treated acidic normal human immunoglobulin (subcutaneous injection) and Vorhyaluronidase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Change | Drugs with a new indication and a new dosage for inhibiting progression of motor disability due to chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy (in the cases where patients show an improvement in their acute phase treatment). |
| Jun 24, 2025 | SpydiaDiazepam | Aculys Pharma, Inc. | New approval | Drugs with a new route of administration indicated for the treatment of status epilepticus. [Orphan drug] |
| Jun 24, 2025 | VelsipityEtrasimod L-arginine | Pfizer Japan Inc. | New ingredient | A drug with a new active ingredient indicated for the treatment of moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). |
| Jun 24, 2025 | LialdaMesalazine | Mochida Pharmaceutical Co., Ltd. | New approval | (1) A drug with a new dosage in an additional dosage form indicated for the treatment of ulcerative colitis (excluding severe cases). (2) A drug with a new dosage indicated for the treatment of ulcerative colitis (excluding severe cases). |
| Jun 24, 2025 | PombilitiCipaglucosidase alfa (genetical recombination) | Amicus Therapeutics, Inc. | New ingredient | A drug with a new active ingredient indicated for use as a combination therapy with miglustat for the treatment of late-onset Pompe disease (LOPD). [Orphan drug] |
| Jun 24, 2025 | OpfoldaMiglustat | Amicus Therapeutics, Inc. | New approval | A drug with a new indication and a new dosage in an additional dosage form for use as a combination therapy with cipaglucosidase alfa (genetical recombination) for the treatment of late-onset Pompe disease (LOPD). [Orphan drug] |
| Jun 24, 2025 | AmvuttraVutrisiran sodium | Alnylam Japan, K.K. | Change | A drug with a new indication for the treatment of transthyretin cardiac amyloidosis (wild-type and hereditary). [Orphan drug] |
| Jun 24, 2025 | AirwinSotatercept (genetical recombination) | MSD K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of pulmonary arterial hypertension. [Orphan drug] |
| Jun 24, 2025 | WeliregBelzutifan | MSD K.K. | New ingredient | (1) A drug with a new active ingredient indicated for the treatment of unresectable or metastatic renal cell carcinoma that has progressed after cancer chemotherapy. (2) A drug with a new active ingredient indicated for the treatment of von Hippel-Lindau disease-associated tumors. [Orphan Drug (only for [2])] |
| Jun 24, 2025 | InrebicFedratinib hydrochloride hydrate | Bristol-Myers Squibb K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of myelofibrosis. [Orphan drug] |
| Jun 24, 2025 | TalveyTalquetamab (genetical recombination) | Janssen Pharmaceutical K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to standard therapies). [Orphan drug] |
| Jun 24, 2025 | RinvoqUpadacitinib hydrate | AbbVie GK | Change | Drugs with a new indication and a new dosage for the treatment of giant cell arteritis in patients who have not responded sufficiently to conventional treatments. |
| Jun 24, 2025 | TremfyaGuselkumab (genetical recombination) | Janssen Pharmaceutical K.K. | Change | Drugs with a new indication and a new dosage for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). |
| Jun 24, 2025 | NespDarbepoetin alfa (genetical recombination) | [1] Kyowa Kirin Co., Ltd., [2] Kyowa Kirin Frontier Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of anemia resulting from the administration of belzutifan. |
| Jun 24, 2025 | OpdivoNivolumab (genetical recombination) | Ono Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable hepatocellular carcinoma. |
| Jun 24, 2025 | YervoyIpilimumab (genetical recombination) | Bristol-Myers Squibb K.K. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable hepatocellular carcinoma. |
| Jun 24, 2025 | Elrexfio S.C.Elranatamab (genetical recombination) | Pfizer Japan Inc. | Change | Drugs with a new dosage indicated for the treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to standard therapies). [Orphan drug] |
| May 19, 2025 | SlindaDrospirenone | ASKA Pharmaceutical Co., Ltd. | New approval | A drug with a new indication, a new dosage, and other characteristics for contraception. |
| May 19, 2025 | FabhaltaIptacopan hydrochloride hydrate | Novartis Pharma K.K. | Change | A drug with a new indication for the treatment of complement 3 glomerulopathy. [Orphan drug] |
| May 19, 2025 | VabysmoFaricimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of choroidal neovascularization associated with angioid streaks. [Orphan drug] |
| May 19, 2025 | mRESVIAmRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation | Moderna Japan Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the prevention of disease caused by RS virus infection. |
| May 19, 2025 | BlenrepBelantamab mafodotin (genetical recombination) | GlaxoSmithKline K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma. [Orphan drug] |
| May 19, 2025 | TagrissoOsimertinib mesilate | AstraZeneca K.K. | Change | Drugs with a new indication for the maintenance treatment for locally-advanced, unresectable epidermal growth factor receptor (EGFR) mutation-positive non- small cell lung cancer following definitive chemoradiation therapy. |
| May 19, 2025 | SpikevaxmRNA encoding the spike protein of SARS- CoV-2 | Moderna Japan Co., Ltd. | Change | A drug with a new additional pediatric dosage indicated for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). |
| May 19, 2025 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication for the treatment of unresectable advanced or recurrent malignant pleural mesothelioma. |
| May 19, 2025 | ScemblixAsciminib hydrochloride | Novartis Pharma K.K. | Change | Drugs with a new indication and a new dosage for the treatment of chronic myelogenous leukemia. |
| May 19, 2025 | RybrevantAmivantamab (genetical recombination) | Janssen Pharmaceutical K.K. | Change | A drug with a new dosage indicated for the treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR ) mutation-positive non-small cell lung cancer. |
| Mar 27, 2025 | TremfyaGuselkumab (genetical recombination) | Janssen Pharmaceutical K.K. | New approval | (1) A drug with a new route of administration indicated for the remission induction therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). (2)(3) Drugs with a new indication and a new dosage in an additional dosage form for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). (4) A drug with a new indication and a new dosage for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). |
| Mar 27, 2025 | LivmarliMaralixibat chloride | Takeda Pharmaceutical Company Limited | New ingredient | A drug with a new active ingredient indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. [Orphan drug] |
| Mar 27, 2025 | Bepio WashBenzoyl peroxide | Maruho Co., Ltd. | New approval | A drug with a new dosage in an additional dosage form indicated for the treatment of acne vulgaris. |
| Mar 27, 2025 | RituxanRituximab (genetical recombination) | Zenyaku Kogyo Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of nephrotic syndrome (frequently relapsing or steroid-dependent nephrotic syndrome). |
| Mar 27, 2025 | OmvohMirikizumab (genetical recombination) | Eli Lilly Japan K.K. | Change | (1) A drug with a new indication and a new dosage for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). (2)(3) Drugs with a new indication, a new dosage, and other characteristics for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). (4)(5) Drugs with a new indication and a new dosage in an additional dosage form for the treatment of moderate to severe active Crohn's disease (for use only in patients who have not sufficiently responded to conventional treatments). |
| Mar 27, 2025 | BeyonttraAcoramidis hydrochloride | Alexion Pharma GK | New ingredient | A drug with a new active ingredient indicated for the treatment of transthyretin cardiac amyloidosis (wild-type and hereditary). |
| Mar 27, 2025 | CamzyosMavacamten | Bristol-Myers Squibb K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy. [Orphan drug] |
| Mar 27, 2025 | Rivaluen LARivastigmine | Towa Pharmaceutical Co., Ltd. | New approval | Drugs in a new dosage form for indicated for inhibiting progression of symptoms of dementia in patients with mild and moderate Alzheimer's disease. |
| Mar 27, 2025 | CarbostarN/A for this combination drug | Yoshindo Inc. | New approval | Combination prescription drugs with similar formulations to be used as perfusion fluids for hemodialysis in patients with chronic renal failure (use in any of the following cases: • When the patient’s blood sugar level is not controlled well with sugarless dialysate. • When dialysate with a high calcium concentration may cause hypercalcemia). |
| Mar 27, 2025 | PrevymisLetermovir | MSD K.K. | Change | (1) Drugs with a new pediatric dosage in an additional dosage form indicated for the prophylaxis of cytomegalovirus disease in organ transplantation. (2) Drugs with a new pediatric dosage in an additional dosage form indicated for the prophylaxis of cytomegalovirus disease in allogeneic hematopoietic stem cell transplantation. [Orphan Drug (only for [2])] |
| Mar 27, 2025 | DupixentDupilumab (genetical recombination) | Sanofi K.K. | Change | Drugs with a new indication and a new dosage for the treatment of chronic obstructive pulmonary disease (for use only in patients who have not responded sufficiently to conventional treatments). |
| Mar 27, 2025 | OtezlaApremilast | Amgen K.K. | Change | Drugs with a new indication for the treatment of palmoplantar pustulosis in patients who have not responded sufficiently to local treatment. |
| Mar 27, 2025 | IlarisCanakinumab (genetical recombination) | Novartis Pharma K.K. | Change | A drug with a new indication and a new dosage for the treatment of adult-onset Still's disease in patients who have not responded sufficiently to conventional treatments. [Orphan drug] |
| Mar 27, 2025 | TevimbraTislelizumab (genetical recombination) | BeiGene Japan GK | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent esophageal cancer. |
| Mar 27, 2025 | LazcluzeLazertinib mesilate hydrate | Janssen Pharmaceutical K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) mutation- positive non-small cell lung cancer. |
| Mar 27, 2025 | TivdakTisotumab vedotin (genetical recombination) | Genmab K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of advanced or recurrent cervical cancer that has progressed after cancer chemotherapy. |
| Mar 27, 2025 | TibsovoIvosidenib | Nihon Servier Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of IDH1 mutation-positive acute myeloid leukemia. [Orphan drug] |
| Mar 27, 2025 | VenclextaVenetoclax | AbbVie GK | Change | Drugs with a new indication and a new dosage for the treatment of relapsed or refractory mantle cell lymphoma. [Orphan drug] |
| Mar 27, 2025 | ImfinziDurvalumab (genetical recombination) | AstraZeneca K.K. | Change | Drugs with a new indication and a new dosage for maintenance treatment of limited-stage small cell lung cancer following definitive chemoradiation therapy. [Orphan drug] |
| Mar 27, 2025 | RybrevantAmivantamab (genetical recombination) | Janssen Pharmaceutical K.K. | Change | A drug with a new indication and a new dosage for the treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) mutation- positive non-small cell lung cancer. |
| Mar 27, 2025 | Ustekinumab BSUstekinumab (genetical recombination) [ustekinumab biosimilar 3] | Celltrion Healthcare Japan K.K. | New approval | A biosimilar indicated for the treatment of the following disease in patients who have not sufficiently responded to conventional therapies: plaque psoriasis and psoriatic arthritis. |
| Mar 27, 2025 | DaichironamRNA encoding the spike protein of SARS- CoV-2 | Daiichi Sankyo Company, Limited | Change | A drug with a new additional pediatric dosage indicated for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). |
| Feb 20, 2025 | LixianaEdoxaban tosilate hydrate | Daiichi Sankyo Company, Limited | Change | Drugs with a new indication for the prevention of thrombus/embolus formation in patients with chronic thromboembolic pulmonary hypertension. |
| Feb 20, 2025 | Andembry S.C.Garadacimab (genetical recombination) | CSL Behring K.K. | New ingredient | A drug with a new active ingredient indicated for the prophylaxis of acute attacks of hereditary angioedema. |
| Feb 20, 2025 | HumiraAdalimumab (genetical recombination) | AbbVie GK | Change | Drugs with a new indication and a new dosage for the treatment of non-radiographic axial spondyloarthritis in patients who have not responded sufficiently to conventional treatments. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Feb 20, 2025 | TecentriqAtezolizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable alveolar soft part sarcoma. |
| Feb 20, 2025 | EpkinlyEpcoritamab (genetical recombination) | Genmab K.K. | Change | Drugs with a new dosage indicated for the treatment of relapsed or refractory follicular lymphoma (Grade 1 to Grade 3 A). |
| Feb 20, 2025 | SarclisaIsatuximab (genetical recombination) | Sanofi K.K. | Change | Drugs with a new indication and a new dosage for the treatment of multiple myeloma. |
| Feb 20, 2025 | RevlimidLenalidomide hydrate | Bristol-Myers Squibb K.K | Change | Drugs with a new dosage indicated for the treatment of multiple myeloma. |
| Dec 27, 2024 | ZeposiaOzanimod hydrochloride | Bristol-Myers Squibb K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). |
| Dec 27, 2024 | OldaminMonoethanolamine oleate | Fuji Chemical Industries Co., Ltd. | Change | A drug with a new indication and a new dosage for the use in sclerotherapy of venous malformation. |
| Dec 27, 2024 | ZepboundTirzepatide | Eli Lilly Japan K.K. | New approval | Drugs with a new indication, a new dosage, and other characteristics for the treatment of obesity. For use only in patients with any of hypertension, hyperlipidemia or type 2 diabetes mellitus who have not responded sufficiently to diet therapy and exercise therapy, and meet the following conditions: • BMI of 27 kg/m 2 or greater in the presence of at least two obesity-related comorbidities or • BMI of 35 kg/m 2 or greater |
| Dec 27, 2024 | UptraviSelexipag | Nippon Shinyaku Co., Ltd. | Change | (1), (2) Drugs with a new additional pediatric dosage and other characteristics and (3) a drug with a new additional pediatric dosage in an additional dosage form, indicated for the treatment of pulmonary arterial hypertension. [Orphan drug] |
| Dec 27, 2024 | Tauvid18 F) | PDRadiopharma Inc. | New ingredient | A drug with a new active ingredient indicated for the support of selection of patients with mild cognitive impairment and mild dementia due to Alzheimer's disease, for whom donanemab (genetical recombination) is indicated. [Expedited review] |
| Dec 27, 2024 | VyvduraEfgartigimod alfa (genetical recombination) and Vorhyaluronidase alfa (genetical recombination) | Argenx Japan K.K. | Change | A drug with a new indication and a new dosage for the treatment of chronic inflammatory demyelinating polyneuropathy. [Orphan drug] |
| Dec 27, 2024 | Qalsody IntrathecalTofersen | Biogen Japan Ltd. | New ingredient | A drug with a new active ingredient indicated for slowing the progression of functional impairment in patients with amyotrophic lateral sclerosis with SOD1 mutation. [Orphan drug] |
| Dec 27, 2024 | Ryjusea Mini ophthalmic solutionAtropine sulfate hydrate | Santen Pharmaceutical Co., Ltd. | New approval | A drug with a new indication in a new dosage form for slowing the progression of myopia. |
| Dec 27, 2024 | TepoxxTecovirimat hydrate | Japan Biotechno Pharma Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of smallpox, mpox, cowpox, as well as complications due to replication of vaccinia virus following vaccination against smallpox . [Expedited review] |
| Dec 27, 2024 | KavigaleSipavibart (genetical recombination) | AstraZeneca K.K. | New ingredient | A drug with a new active ingredient indicated for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). [Expedited review] |
| Dec 27, 2024 | FasenraBenralizumab (genetical recombination) | AstraZeneca K.K. | Change | (1) A drug with a new indication and a new dosage and (2) a drug with a new indication and a new dosage in an additional dosage form, indicated for the treatment of eosinophilic granulomatosis with polyangiitis in patients who have not responded sufficiently to conventional therapies. |
| Dec 27, 2024 | BrukinsaZanubrutinib | BeiGene Japan GK. | New ingredient | A drug with a new active ingredient indicated for the treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma), Waldenström's macroglobulinemia, and lymphoplasmacytic lymphoma. |
| Dec 27, 2024 | BalversaErdafitinib | Janssen Pharmaceutical K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of unresectable urothelial carcinoma with FGFR 3 gene mutation or fusion gene that has progressed after cancer chemotherapy. |
| Dec 27, 2024 | CalquenceAcalabrutinib maleate hydrate | AstraZeneca K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of chronic lymphocytic leukemia (including small lymphocytic lymphoma). |
| Dec 27, 2024 | DatrowayDatopotamab deruxtecan (genetical recombination) | Daiichi Sankyo Company, Limited | New ingredient | A drug with a new active ingredient indicated for the treatment of hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative unresectable or recurrent breast cancer in patients who have previously been treated with chemotherapy. |
| Dec 27, 2024 | LunsumioMosunetuzumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of relapsed or refractory follicular lymphoma. |
| Dec 27, 2024 | ImdelltraTarlatamab (genetical recombination) | Amgen K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of small cell lung cancer that has progressed after cancer chemotherapy. [Orphan drug] |
| Dec 27, 2024 | TecvayliTeclistamab (genetical recombination) | Janssen Pharmaceutical K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to standard therapies). [Orphan drug] |
| Dec 27, 2024 | OpdivoNivolumab (genetical recombination) | Ono Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable urothelial carcinoma. |
| Dec 27, 2024 | RandaCisplatin | Nippon Kayaku Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of urothelial carcinoma. |
| Dec 27, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the treatment of advanced or recurrent endometrial cancer. [Orphan drug] |
| Dec 27, 2024 | Ustekinumab BSUstekinumab (genetical recombination) [ustekinumab biosimilar 2] | Yoshindo Inc. | New approval | A biosimilar indicated for the treatment of the following disease in patients who have not sufficiently responded to conventional therapies: plaque psoriasis and psoriatic arthritis |
| Dec 27, 2024 | Efluelda intramuscular injectionInfluenza virus (type A and type B) HA fraction | Sanofi K.K. | New ingredient | A drug with a new active ingredient indicated for the prevention of influenza. |
| Dec 27, 2024 | HyQviaHuman normal immunoglobulin G (pH4-treated acidic normal human immunoglobulin [subcutaneous injection]) and Vorhyaluronidase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | New ingredient | Drugs with a new active ingredient indicated for the treatment of agammaglobulinemia or hypogammaglobulinemia. |
| Dec 27, 2024 | Hympavzi S.C.Marstacimab (genetical recombination) | Pfizer Japan Inc. | New ingredient | A drug with a new active ingredient indicated for the control of bleeding tendency in patients with congenital haemophilia who do not have inhibitors against blood coagulation factor VIII or IX. |
| Nov 22, 2024 | RevoladeEltrombopag olamine | Novartis Pharma K.K. | Change | Drugs with a new additional pediatric dosage indicated for the treatment of chronic idiopathic thrombocytopenic purpura. [Public knowledge-based application after preliminary assessment by the Pharmaceutical Affairs and Food Sanitation Council (PAFSC)] |
| Nov 22, 2024 | RomiplateRomiplostim (genetical recombination) | Kyowa Kirin Co., Ltd. | Change | A drug with a new additional pediatric dosage indicated for the treatment of chronic idiopathic thrombocytopenic purpura. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Nov 22, 2024 | RituxanRituximab (genetical recombination) | Zenyaku Kogyo Co., Ltd. | Change | Drugs with a new additional pediatric dosage indicated for the treatment of chronic idiopathic thrombocytopenic purpura. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Nov 22, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the treatment of locally advanced cervical cancer. [Orphan drug] |
| Nov 22, 2024 | ImfinziDurvalumab (genetical recombination) | AstraZeneca K.K. | Change | Drugs with a new indication and a new dosage for the treatment of advanced or recurrent endometrial cancer. |
| Nov 22, 2024 | LynparzaOlaparib | AstraZeneca K.K. | Change | Drugs with a new indication and a new dosage for the maintenance therapy of advanced or recurrent endometrial cancer with proficient mismatch repair (pMMR) in patients who have received chemotherapy including treatment with durvalumab (genetical recombination). |
| Nov 22, 2024 | RandaCisplatin | Nippon Kayaku Co., Ltd. | Change | Drugs with a new dosage indicated for the treatment of cervical cancer. [Expedited review] |
| Nov 22, 2024 | ArexvyRecombinant respiratory syncytial virus PreF3 antigen | GlaxoSmithKline K.K. | Change | A drug with a new dosage indicated for the prevention of disease caused by RS virus infection in individuals aged 50 years or older who are considered to be at a high risk of developing severe RS virus infection. |
| Sep 24, 2024 | VeltassaPatiromer sorbitex calcium | Zeria Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of hyperkalaemia. |
| Sep 24, 2024 | LupkynisVoclosporin | Otsuka Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of lupus nephritis. |
| Sep 24, 2024 | Venoglobulin IHPolyethylene glycol treated human normal immunoglobulin | Japan Blood Products Organization | Change | Drugs with new indications and a new dosage for the treatment of antibody-mediated rejection in the following organ transplantations; kidney transplantation, liver transplantation, heart transplantation, lung transplantation, pancreas transplantation, small intestine transplantation. [Orphan drug] |
| Sep 24, 2024 | RituxanRituximab (genetical recombination) | Zenyaku Kogyo Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of refractory nephrotic syndrome (for use steroid-resistant nephrotic syndrome). [Orphan drug] |
| Sep 24, 2024 | JakaviRuxolitinib phosphate | Novartis Pharma K.K. | Change | Drugs with a new indication and a new additional pediatric dosage and a drug with a new indication and a new additional pediatric dosage in an additional dosage form for the treatment of graft-versus-host disease after hematopoietic stem cell transplantation (for use when steroid drugs are not sufficiently effective). [Orphan drug] |
| Sep 24, 2024 | TepezzaTeprotumumab (genetical recombination) | Amgen K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of active thyroid eye disease. [Orphan drug] |
| Sep 24, 2024 | KisunlaDonanemab (genetical recombination) | Eli Lilly Japan K.K. | New ingredient | A drug with a new active ingredient indicated for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease. |
| Sep 24, 2024 | YuvanciMacitentan/Tadalafil | Janssen Pharmaceutical K.K. | New approval | A new combination drug indicated for the treatment of pulmonary arterial hypertension. |
| Sep 24, 2024 | TreprostTreprostinil | Mochida Pharmaceutical Co., Ltd. | Change | A drug with a new indication and a new dosage for the treatment of pulmonary hypertension associated with interstitial lung disease. [Orphan drug] |
| Sep 24, 2024 | AlyssaEstetrol hydrate/Drospirenone | Fuji Pharma Co., Ltd. | New ingredient | A new combination drug with a new active ingredient indicated for the treatment of dysmenorrhea. |
| Sep 24, 2024 | KidparenN/A for this combination drug | Otsuka Pharmaceutical Factory, Inc. | New approval | A combination prescription drug with similar formulations indicated for the supplementation of water, electrolytes, calories, amino acids, and vitamins in patients with chronic renal failure (for use only in patients with or at a risk of hyperkalemia or hyperphosphatemia) for whom receiving oral or enteral nutrition is impossible or insufficient and the total parenteral nutrition is the only choice. |
| Sep 24, 2024 | Enosolid Semi SolidN/A for this combination drug | EN Otsuka Pharmaceutical Co., Ltd. | New approval | A combination prescription drug with similar formulations indicated for tube feeding, especially for patients with long-term oral feeding difficulties. It also generally can be used for nutrient retention for postoperative patients. |
| Sep 24, 2024 | Alaglio DividedAminolevulinic acid hydrochloride | SBI Pharmaceuticals Co., Ltd. | Change | Drugs with a new dosage and other characteristics indicated for the visualization of tumor tissues of the non-muscle invasive bladder cancer in transurethral resection of bladder tumor. [Orphan drug] |
| Sep 24, 2024 | RexultiBrexpiprazole | Otsuka Pharmaceutical Co., Ltd. | Change | Drugs with new indications and a new dosage for the treatment of excessive motor activity or verbal/physical aggression attributable to rapid changes in mood and/or irritability, outburst associated with Alzheimer's dementia. |
| Sep 24, 2024 | QuviviqDaridorexant hydrochloride | Nexera Pharma Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of insomnia. |
| Sep 24, 2024 | FirdapseAmifampridine phosphate | DyDo Pharma, Inc. | New ingredient | A drug with a new active ingredient indicated for the improvement of muscle weakness in patients with Lambert-Eaton myasthenic syndrome. [Orphan drug] |
| Sep 24, 2024 | RozebalaminMecobalamin | Eisai Co., Ltd. | New approval | A drug with a new indication and a new dosage in an additional dosage form for slowing the progression of functional impairment in patients with amyotrophic lateral sclerosis (ALS). [Orphan drug] |
| Sep 24, 2024 | EvrysdiRisdiplam | Chugai Pharmaceutical Co., Ltd. | Change | A drug with a new indication and a new additional pediatric dosage (under 2 months of age) for the treatment of spinal muscular atrophy. [Orphan drug] |
| Sep 24, 2024 | SeptocaineArticaine hydrochloride/ Adrenaline bitartrate | GC Showayakuhin Corporation | New ingredient | A new combination drug with a new active ingredient indicated for infiltration anesthesia or nerve block in the fields of dentistry and oral surgery. |
| Sep 24, 2024 | BimzelxBimekizumab (genetical recombination) | UCB Japan Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of hidradenitis suppurativa. |
| Sep 24, 2024 | RinvoqUpadacitinib hydrate | AbbVie GK | Change | Drugs with a new additional pediatric dosage indicated for the treatment of atopic dermatitis in patients who have not responded sufficiently to conventional treatments. |
| Sep 24, 2024 | FruzaqlaFruquintinib | Takeda Pharmaceutical Company Limited | New ingredient | Drugs with a new active ingredient indicated for the treatment of unresectable advanced or recurrent colon or rectal cancer that has progressed after cancer chemotherapy. |
| Sep 24, 2024 | TasfygoTasurgratinib succinate | Eisai Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable FGFR2 fusion gene-positive biliary tract cancer that has progressed after cancer chemotherapy. [Orphan drug] |
| Sep 24, 2024 | AugtyroRepotrectinib | Bristol-Myers Squibb K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of ROS1 fusion gene-positive unresectable advanced or recurrent non-small-cell lung cancer. |
| Sep 24, 2024 | RybrevantAmivantamab (genetical recombination) | Janssen Pharmaceutical K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent epidermal growth factor receptor (EGFR) gene exon 20 insertion mutation-positive non-small cell lung cancer. |
| Sep 24, 2024 | TrodelvySacituzumab govitecan (genetical recombination) | Gilead Sciences, Inc. | New ingredient | A drug with a new active ingredient indicated for the treatment of hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative unresectable or recurrent breast cancer in patients who have previously been treated with chemotherapy. [Priority review] |
| Sep 24, 2024 | PadcevEnfortumab vedotin (genetical recombination) | Astellas Pharma Inc. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable urothelial carcinoma. [Priority review] |
| Sep 24, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication for the treatment of unresectable urothelial carcinoma. [Priority review] |
| Sep 24, 2024 | Tafinlar DispersibleDabrafenib mesilate | Novartis Pharma K.K. | New approval | (1) A drug with a new indication and a new dosage in an additional dosage form for the treatment of BRAF mutation-positive low-grade glioma. (2) (3) Drugs with a new indication for the treatment of BRAF mutation-positive low-grade glioma. [Orphan drug] |
| Sep 24, 2024 | MekinistTrametinib dimethyl sulfoxide | Novartis Pharma K.K. | New approval | (1) A drug with a new indication and a new dosage in an additional dosage form for the treatment of BRAF mutation-positive low-grade glioma. (2) (3) Drugs with a new indication for the treatment of BRAF mutation-positive low-grade glioma. [Orphan drug] |
| Sep 24, 2024 | Mearubik IILive attenuated measles virus (Tanabe strain) and live attenuated rubella virus (Matsuura/J16 strain) | The Research Foundation for Microbial Diseases of Osaka University | New ingredient | A new combination drug with a new active ingredient indicated for the prevention of measles and rubella. |
| Sep 24, 2024 | NovoSeven HIEptacog alfa (activated) (genetical recombination) | Novo Nordisk Pharma Ltd. | Change | Drugs with a new indication and a new dosage for the control of bleeding tendency in patients with Glantzmann thrombasthenia. [Public knowledge-based application] |
| Sep 13, 2024 | KostaivemRNA encoding the spike protein of SARS- CoV-2 (Omicron JN.1 variant) | Meiji Seika Pharma Co., Ltd. | Change | A drug with a new indication, a new dosage, and other characteristics for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). [Expedited review] |
| Sep 5, 2024 | NuvaxovidSARS-CoV-2 rS (Omicron JN.1 variant) | Takeda Pharmaceutical Company Limited | New approval | A drug with a new indication, a new dosage, and other characteristics in an additional dosage form for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). |
| Aug 28, 2024 | AzilvaAzilsartan | Takeda Pharmaceutical Company Limited | Change | Drugs with a new additional pediatric dosage (aged 2 years to 5 years) indicated for the treatment of hypertension. |
| Aug 28, 2024 | NucalaMepolizumab (genetical recombination) | GlaxoSmithKline K.K. | Change | Drugs with a new indication and a new dosage for the treatment of chronic rhinosinusitis with nasal polyps (for use only in patients who have not responded sufficiently to conventional treatments). |
| Aug 28, 2024 | TruvadaEmtricitabine/ Tenofovir disoproxil fumarate | Gilead Sciences, Inc. | Change | A drug with a new indication and a new dosage for the pre-exposure prophylaxis against HIV-1 infection. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Aug 28, 2024 | AlecensaAlectinib hydrochloride | Chugai Pharmaceutical Co., Ltd. | Change | A drug with a new indication, a new dosage, and other characteristics for the postoperative adjuvant treatment for anaplastic lymphoma kinase (ALK ) fusion gene- positive non-small cell lung cancer. [Orphan drug] |
| Aug 28, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the preoperative and postoperative adjuvant treatment for non-small cell lung cancer. |
| Aug 28, 2024 | AlimtaPemetrexed sodium hydrate | Eli Lilly Japan K.K. | Change | Drugs with a new indication and a new dosage for the preoperative adjuvant treatment for non-squamous non- small cell lung cancer. |
| Aug 28, 2024 | PemetrexedPemetrexed sodium hemipentahydrate | Nippon Kayaku Co., Ltd. | Change | Drugs with a new dosage for the preoperative adjuvant treatment for non-squamous non-small cell lung cancer. |
| Aug 28, 2024 | Prevenar20Pneumococcal polysaccharide conjugated to CRM197 carrier protein | Pfizer Japan Inc. | Change | A drug with a new indication and a new dosage for the prophylaxis of pneumococcal disease in the elderly and in individuals who are considered to be at a high risk of pneumococcal disease. |
| Jun 24, 2024 | NexiumEsomeprazole magnesium hydrate | AstraZeneca K.K. | Change | Drugs with a new additional pediatric dosage indicated for the prevention of recurrent reflux esophagitis and gastric or duodenal ulcer after dosing non-steroid anti- inflammatory drugs, and prevention of recurrent gastric or duodenal ulcer after dosing low-dose aspirins. |
| Jun 24, 2024 | FabhaltaIptacopan hydrochloride hydrate | Novartis Pharma K.K. | New ingredient | A drug with a new active ingredient indicated for the treatment of paroxysmal nocturnal haemoglobinuria. |
| Jun 24, 2024 | VtamaTapinarof | Japan Tobacco Inc. | New ingredient | A drug with a new active ingredient indicated for the treatment of atopic dermatitis and plaque psoriasis. |
| Jun 24, 2024 | SkyriziRisankizumab (genetical recombination) | AbbVie GK | Change | 1) A drug with a new indication and a new dosage for the remission induction therapy of moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). (2) (3) Drugs with a new indication and a new dosage in an additional dosage form for the maintenance therapy for moderate to severe ulcerative colitis (for use only in patients who have not sufficiently responded to conventional treatments). |
| Jun 24, 2024 | AwiqliInsulin icodec (genetical recombination) | Novo Nordisk Pharma Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of diabetes mellitus in cases where insulin therapy is indicated. |
| Jun 24, 2024 | TrulicityDulaglutide (genetical recombination) | Eli Lilly Japan K.K. | Change | （1） A drug with a new dosage for the treatment of type 2 diabetes mellitus. （2） A drug with a new dosage in an additional dosage form for the treatment of type 2 diabetes mellitus. |
| Jun 24, 2024 | BriviactBrivaracetam | UCB Japan Co., Ltd. | New ingredient | (1) (2) Drugs with a new active ingredient indicated for the treatment of partial seizures (including secondary generalized seizures) in patients with epilepsy. (3) A drug with a new active ingredient indicated for the following treatment; partial seizures (including secondary generalized seizures) in patients with epilepsy. It is used as an alternative therapy for blevaracetam oral formulation in patients who are temporarily unable to be administered orally. |
| Jun 24, 2024 | BotoxBotulinum toxin type A | GlaxoSmithKline K.K. | Change | Drugs with a new indication and a new additional pediatric dosage for the treatment of upper and lower limb spasticity. |
| Jun 24, 2024 | AviganFavipiravir | Fujifilm Toyama Chemical Co., Ltd. | Change | A drug with a new indication and a new dosage for the treatment of severe fever with thrombocytopenia syndrome virus infection. [Orphan drug] |
| Jun 24, 2024 | ZaviceftaAvibactam sodium/Ceftazidime hydrate | Pfizer Japan Inc. | New ingredient | A new combination drug with a new active ingredient indicated for the treatment of sepsis, pneumonia, cystitis, pyelonephritis, peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess caused by Zavicefta-sensitive Escherichia coli , Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Proteus spp., Morganella morganii , Haemophilus influenzae , and Pseudomonas aeruginosa . |
| Jun 24, 2024 | LivtencityMaribavir | Takeda Pharmaceutical Company Limited | New ingredient | A drug with a new active ingredient indicated for the treatment of cytomegalovirus disease in organ transplantation (including hematopoietic stem cell transplantation) that is refractory to conventional anti- cytomegalovirus therapy. [Orphan drug] |
| Jun 24, 2024 | RelvarFluticasone furoate/Vilanterol trifenatate | GlaxoSmithKline K.K. | New approval | (1) (2) New combination drugs with a new additional pediatric dosage indicated for the treatment of bronchial asthma (when a combination treatment of an inhaled steroid and a long-acting beta-2 agonist is needed). (3) (4) Drugs with a new additional pediatric dosage indicated for the treatment of bronchial asthma (when a combination treatment of an inhaled steroid and a long- acting beta-2 agonist is needed). |
| Jun 24, 2024 | BenlystaBelimumab (genetical recombination) | GlaxoSmithKline K.K. | Change | A drug with a new additional pediatric dosage indicated for the treatment of systemic lupus erythematosus in patients who have not responded sufficiently to conventional treatments. |
| Jun 24, 2024 | CellceptMycophenolate mofetil | Chugai Pharmaceutical Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of systemic sclerosis-associated interstitial lung disease. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Jun 24, 2024 | JaypircaPirtobrutinib | Eli Lilly Japan K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of relapsed or refractory mantle cell lymphoma with resistance or intolerance to other BTK inhibitors. |
| Jun 24, 2024 | TargretinBexarotene | Minophagen Pharmaceutical Co., Ltd. | Change | A drug with a new indication for the treatment of adult T- cell leukemia/lymphoma with skin lesions. |
| Jun 24, 2024 | OmjjaraMomelotinib hydrochloride hydrate | GlaxoSmithKline K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of myelofibrosis. |
| Jun 24, 2024 | HaiyitanGumarontinib hydrate | Haihe Biopharma K. K. | New ingredient | A drug with a new active ingredient indicated for the treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive non- small cell lung cancer. |
| Jun 24, 2024 | RetevmoSelpercatinib | Eli Lilly Japan K.K. | Change | Drugs with a new indication and a new dosage for the treatment of RET fusion gene-positive advanced or recurrent solid tumor. [Orphan drug] |
| Jun 24, 2024 | EzharmiaValemetostat tosilate | Daiichi Sankyo Company, Limited | Change | Drugs with a new indication for the treatment of relapsed or refractory peripheral T-cell lymphoma. [SAKIGAKE review] |
| Jun 24, 2024 | ParaplatinCarboplatin | Clinigen K.K. | Change | Drugs with a new indication and a new dosage for the treatment of endometrial cancer. [Public knowledge-based application after PAFSC's preliminary assessment] |
| Jun 24, 2024 | Aflibercept BSAflibercept (genetical recombination) [aflibercept biosimilar 1] | Global Regulatory Partners GK | New approval | A biosimilar indicated for the treatment of macular edema following retinal vein occlusion, choroidal neovascularization in patients with pathologic myopia, and diabetic macular edema. |
| Jun 24, 2024 | CovgozeRecombinant coronavirus (SARS- CoV-2) spike protein antigen | Shionogi & Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the prevention of disease caused by SARS-CoV-2 infection (COVID-19). [Priority review] |
| Jun 24, 2024 | Typhim ViSalmonella typhi (TY2 strain) purified Vi capsular polysaccharide | Sanofi K.K. | New ingredient | A drug with a new active ingredient indicated for the prevention of typhoid fever. |
| Jun 24, 2024 | AlhemoConcizumab (genetical recombination) | Novo Nordisk Pharma Ltd. | Change | Drugs with a new indication for the control of bleeding tendency in patients with congenital haemophilia who do not have inhibitors against blood coagulation factor VIII or IX. |
| May 17, 2024 | PrevymisLetermovir | MSD K.K. | Change | Drugs with a new indication for the prophylaxis of cytomegalovirus disease in organ transplantation. |
| May 17, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer. |
| May 17, 2024 | BraftoviEncorafenib | Ono Pharmaceutical Co., Ltd. | Change | Drugs with new indications and a new dosage for the treatments of unresectable BRAF mutation-positive thyroid cancer that has progressed after cancer chemotherapy and unresectable BRAF mutation- positive anaplastic thyroid cancer. |
| May 17, 2024 | MektoviBinimetinib | Ono Pharmaceutical Co., Ltd. | Change | A drug with new indications and a new dosage for the treatments of unresectable BRAF mutation-positive thyroid cancer that has progressed after cancer chemotherapy and unresectable BRAF mutation- positive anaplastic thyroid cancer. |
| May 17, 2024 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Change | A drug with a new indication and a new dosage for the treatment of unresectable biliary tract cancer. |
| May 17, 2024 | G-LastaPegfilgrastim (genetical recombination) | Kyowa Kirin Co., Ltd. | Change | A drug with a new indication for the mobilization of hematopoietic stem cells to the peripheral blood for autologous hematopoietic stem cell transplantation. |
| Mar 26, 2024 | ZintusZinc histidine hydrate | Nobelpharma Co., Ltd. | New ingredient | Drugs with a new active ingredient indicated for the treatment of hypozincemia. |
| Mar 26, 2024 | PiaskyCrovalimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of paroxysmal nocturnal haemoglobinuria. |
| Mar 26, 2024 | RezurockBelumosudil mesilate | Meiji Seika Pharma Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of chronic graft-versus-host disease after hematopoietic stem cell transplantation (for use when steroid drugs are not sufficiently effective). [Orphan drug] |
| Mar 26, 2024 | EntrestoSacubitril valsartan sodium hydrate | Novartis Pharma K.K. | New approval | Drugs with a new indication and a new additional pediatric dosage in an additional dosage form for the treatment of chronic heart failure. |
| Mar 26, 2024 | VyvgartEfgartigimod alfa (genetical recombination) | Argenx Japan K.K. | Change | A drug with a new indication and a new dosage for the treatment of chronic idiopathic thrombocytopenic purpura. [Orphan drug] |
| Mar 26, 2024 | AdzynmaApadamtase alfa (genetical recombination)/ Cinaxadamtase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | New ingredient | A drug with a new active ingredient indicated for the treatment of congenital thrombotic thrombocytopenic purpura. [Orphan drug] |
| Mar 26, 2024 | FinteplaFenfluramine hydrochloride | UCB Japan Co., Ltd. | Change | A drug with a new indication and a new dosage for use as an adjunctive therapy with other antiepileptic drugs to treat epileptic seizures in patients with Lennox-Gastaut syndrome who have not responded sufficiently to other antiepileptic drugs. [Orphan drug] |
| Mar 26, 2024 | Acenobel Extended ReleaseAceneuramic acid | Nobelpharma Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for delaying the progression of muscle weakness in patients with distal myopathy with rimmed vacuoles. [Orphan drug] |
| Mar 26, 2024 | CystadropsCysteamine hydrochloride | Viatris Pharmaceuticals Japan Inc. | New ingredient | A drug with a new active ingredient indicated for the reduction of corneal cystine crystals in patients with cystinosis. [Orphan drug] |
| Mar 26, 2024 | VabysmoFaricimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Change | A drug with a new indication and a new dosage for the treatment of macular edema following retinal vein occlusion. |
| Mar 26, 2024 | BeyfortusNirsevimab (genetical recombination) | AstraZeneca K.K. | New ingredient | Drugs with a new active ingredient indicated for as follows: 1.The prevention of lower respiratory tract disease caused by respiratory syncytial (RS) virus infection in neonates, infants and children at risk of serious RS virus infection entering their first or second RS virus season after birth. 2.The prophylaxis of lower respiratory tract disease caused by RS virus infection in all neonates and infants other than those described in Item 1 entering their first RS virus season after birth. |
| Mar 26, 2024 | RifximaRifaximin | Aska Pharmaceutical Co., Ltd. | Change | A drug with a new additional pediatric dosage indicated for the improvement of hyperammonemia in patients with hepatic encephalopathy. [Orphan drug] |
| Mar 26, 2024 | SynagisPalivizumab (genetical recombination) | AstraZeneca K.K. | Change | Drugs with a new indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial (RS) virus infection in neonates, infants, and children aged 24 months and younger with pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, congenital metabolic disorder, or neuromuscular disease at the early stage of the RS virus season. [Priority review] |
| Mar 26, 2024 | OlumiantBaricitinib | Eli Lilly Japan K.K. | Change | (1), (2) Drugs with a new indication and a new dosage and (3) a drug with a new indication and a new dosage in an additional dosage form, for the treatment of polyarticular-course juvenile idiopathic arthritis in patients who have not responded sufficiently to conventional treatments. |
| Mar 26, 2024 | OlumiantBaricitinib | Eli Lilly Japan K.K. | Change | (1), (2) Drugs with a new additional pediatric dosage and (3) a drug with a new additional pediatric dosage in an additional dosage form, indicated for the treatment of atopic dermatitis in patients who have not responded sufficiently to conventional treatments. |
| Mar 26, 2024 | FasenraBenralizumab (genetical recombination) | AstraZeneca K.K. | Change | (1) A drug with a new additional pediatric dosage and (2) a drug with a new additional pediatric dosage in an additional dosage form, indicated for the treatment of bronchial asthma (for use only in patients with intractable bronchial asthma whose asthmatic responses are uncontrollable with conventional therapies). |
| Mar 26, 2024 | MitchgaNemolizumab (genetical recombination) | Maruho Co., Ltd. | New approval | A drug with a new indication and a new dosage for the treatment of prurigo nodularis in patients who have not responded sufficiently to conventional treatments, and a new additional pediatric dosage in an additional dosage form, indicated for the treatment of pruritus associated with atopic dermatitis in patients who have not responded sufficiently to conventional treatments. |
| Mar 26, 2024 | SargmalinSargramostim (genetical recombination) | Nobelpharma Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of autoimmune pulmonary alveolar proteinosis. [Orphan drug] |
| Mar 26, 2024 | Alesion EyelidEpinastine hydrochloride | Santen Pharmaceutical Co., Ltd. | New approval | A drug in a new dosage form indicated for the treatment of allergic conjunctivitis. |
| Mar 26, 2024 | VyxeosDaunorubicin hydrochloride, Cytarabine | Nippon Shinyaku Co., Ltd. | New approval | A new combination drug indicated for the treatment of high-risk acute myeloid leukemia. [Orphan drug] |
| Mar 26, 2024 | TruqapCapivasertib | AstraZeneca K.K. | New ingredient | Drugs with a new active ingredient indicated for the treatment of hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative inoperable or recurrent breast cancer with PIK3CA, AKT1, or PTEN mutation that has progressed after endocrine therapy. |
| Mar 26, 2024 | VyloyZolbetuximab (genetical recombination) | Astellas Pharma Inc. | New ingredient | A drug with a new active ingredient indicated for the treatment of CLDN18.2 (Claudin-18 splice variant 2)-positive unresectable advanced or recurrent gastric cancer. |
| Mar 26, 2024 | Elrexfio S.C.Elranatamab (genetical recombination) | Pfizer Japan Inc. | New ingredient | Drugs with a new active ingredient indicated for the treatment of relapsed or refractory multiple myeloma (for use only if refractory or intolerant to standard therapies). [Orphan drug] |
| Mar 26, 2024 | BesponsaInotuzumab ozogamicin (genetical recombination) | Pfizer Japan Inc. | Change | A drug with a new additional pediatric dosage indicated for the treatment of relapsed or refractory CD22-positive acute lymphoblastic leukemia. |
| Mar 26, 2024 | FaslodexFulvestrant | AstraZeneca K.K. | Change | A drug with a new dosage indicated for the treatment of breast cancer. |
| Mar 26, 2024 | 5-FUFluorouracil | Kyowa Kirin Co., Ltd. | Change | Drugs with a new indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer. [Public knowledge-based application] |
| Mar 26, 2024 | TicovacInactivated tick-borne encephalitis virus | Pfizer Japan Inc. | New ingredient | Drugs with a new active ingredient indicated for the prevention of tick-borne encephalitis. |
| Mar 26, 2024 | PrevenarPneumococcal polysaccharide conjugated to CRM197 carrier protein | Pfizer Japan Inc. | New ingredient | A drug with a new active ingredient indicated for the prophylaxis of invasive pneumococcal disease (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in children. |
| Mar 26, 2024 | AbrysvoRespiratory syncytial virus-A prefusion F protein Respiratory syncytial virus-B prefusion F protein | Pfizer Japan Inc. | Change | A drug with a new indication and a new dosage for the prevention of disease caused by respiratory syncytial virus infection in individuals 60 years of age and older. |
| Mar 26, 2024 | CeprotinHuman protein C | Takeda Pharmaceutical Company Limited | New ingredient | A drug with a new active ingredient indicated for the treatment of venous thromboembolism and purpura fulminans and for the control of thrombophilia, in patients with congenital protein C deficiency. |
| Mar 26, 2024 | ObizurSusoctocog alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | New ingredient | A drug with a new active ingredient indicated for the control of bleeding episodes in patients with acquired hemophilia A. [Orphan drug] |
| Mar 5, 2024 | XocovaEnsitrelvir fumaric acid | Shionogi & Co., Ltd. | New ingredient | A drug with a new active ingredient indicated for the treatment of disease caused by SARS-CoV-2 infection (COVID-19). |
Gilead Sciences, Inc.
Nobelpharma Co., Ltd.Every New Active Ingredient Since 2008
With the first US approval of the same ingredient in Drugs@FDA. Sort by the gap to find the longest waits.| Feb 19, 2026 | SohonosPalovarotene | IPSEN Co., Ltd. | Hormones and metabolism | Aug 16, 2023 | 30 mo later |
| Feb 19, 2026 | AquiptaAtogepant hydrate | AbbVie GK | Heart, Parkinson's and Alzheimer's | Sep 28, 2021 | 53 mo later |
| Feb 19, 2026 | TukysaTucatinib ethanolate | Pfizer Japan Inc. | Cancer | Apr 17, 2020 | 70 mo later |
| Dec 22, 2025 | ZurzuvaeZuranolone | Shionogi & Co., Ltd. | Nervous system | Aug 4, 2023 | 29 mo later |
| Dec 22, 2025 | SephienceSepiapterin | PTC Therapeutics K.K. | Hormones and metabolism | Jul 28, 2025 | 5 mo later |
| Dec 22, 2025 | RavictiGlycerol phenylbutyrate | OrphanPacific, Inc. | Hormones and metabolism | Feb 1, 2013 | 155 mo later |
| Dec 22, 2025 | PreemieFort(1) (2) Human milk/ Calcium glycerophosphate/ Calcium gluconate hydrate/Calcium chloride hydrate/Anhydrous Sodium Citrate/Potassium citrate/Magnesium monohydrogen phosphate/Zinc sulfate hydrate/Sodium chloride/Copper sulfate (3) Human milk | Clinigen K.K. | Reproductive and urinary | No US match | — |
| Dec 22, 2025 | YseltyLinzagolix choline | Kissei Pharmaceutical Co., Ltd. | Reproductive and urinary | No US match | — |
| Dec 22, 2025 | InluriyoImlunestrant tosilate | Eli Lilly Japan K.K. | Cancer | Sep 25, 2025 | 3 mo later |
| Dec 22, 2025 | ZynyzRetifanlimab (genetical recombination) | Incyte Biosciences Japan G.K. | Cancer | Mar 22, 2023 | 33 mo later |
| Dec 22, 2025 | ElzonrisTagraxofusp (genetical recombination) | Nippon Shinyaku Co., Ltd. | Cancer | Dec 21, 2018 | 84 mo later |
| Dec 22, 2025 | MinjuviTafasitamab (genetical recombination) | Incyte Biosciences Japan G.K. | Cancer | Jul 31, 2020 | 65 mo later |
| Dec 22, 2025 | ExdensurDepemokimab (genetical recombination) | GlaxoSmithKline K.K. | Respiratory and allergy | Dec 16, 2025 | Same month |
| Dec 22, 2025 | EkterlySebetralstat | KalVista Pharmaceuticals Ltd. | Respiratory and allergy | Jul 3, 2025 | 6 mo later |
| Dec 22, 2025 | AvareptMotugivatrep | Senju Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 19, 2025 | NexletolBempedoic acid | Otsuka Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Feb 21, 2020 | 67 mo later |
| Sep 19, 2025 | Nurtec ODRimegepant sulfate hydrate | Pfizer Japan Inc. | Heart, Parkinson's and Alzheimer's | Feb 27, 2020 | 67 mo later |
| Sep 19, 2025 | Ycanth TopicalCantharidin | Torii Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jul 21, 2023 | 26 mo later |
| Sep 19, 2025 | BylvayOdevixibat hydrate | Ipsen Co., Ltd. | Gastrointestinal, skin and immune | Jul 20, 2021 | 50 mo later |
| Sep 19, 2025 | ImaavyNipocalimab (genetical recombination) | Janssen Pharmaceutical K.K. | Nervous system | Apr 29, 2025 | 5 mo later |
| Sep 19, 2025 | IzervayAvacincaptad pegol sodium | Astellas Pharma Inc. | Anesthesia, eye and narcotics | Aug 4, 2023 | 26 mo later |
| Sep 19, 2025 | VoranigoVorasidenib citric acid hydrate | Nihon Servier Co., Ltd. | Cancer | No US match | — |
| Sep 19, 2025 | HernexeosZongertinib | Nippon Boehringer Ingelheim Co., Ltd. | Cancer | Aug 8, 2025 | 1 mo later |
| Sep 19, 2025 | IbtroziTaletrectinib adipate | Nippon Kayaku Co., Ltd. | Cancer | Jun 11, 2025 | 3 mo later |
| Sep 19, 2025 | Pluvicto177 Lu) tetraxetan | Novartis Pharma K.K. | Radiopharmaceuticals | No US match | — |
| Sep 19, 2025 | LocametzGozetotide | Novartis Pharma K.K. | Radiopharmaceuticals | No US match | — |
| Sep 19, 2025 | 6868 Ga) chloride | Not listed | Radiopharmaceuticals | No US match | — |
| Aug 25, 2025 | VorzzzVornorexant hydrate | Taisho Pharmaceutical Co., Ltd. | Nervous system | No US match | — |
| Aug 25, 2025 | SetaneoSepetaprost | Santen Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | No US match | — |
| Aug 25, 2025 | YorvipathPalopegteriparatide | Teijin Pharma Limited | Hormones and metabolism | Aug 9, 2024 | 13 mo later |
| Aug 8, 2025 | CapvaxivePneumococcal 21- valent conjugate vaccine (mutated diphtheria CRM197 conjugate) | MSD K.K. | Vaccines | No US match | — |
| Jun 24, 2025 | VelsipityEtrasimod L-arginine | Pfizer Japan Inc. | Gastrointestinal, skin and immune | No US match | — |
| Jun 24, 2025 | PombilitiCipaglucosidase alfa (genetical recombination) | Amicus Therapeutics, Inc. | Hormones and metabolism | Sep 28, 2023 | 21 mo later |
| Jun 24, 2025 | AirwinSotatercept (genetical recombination) | MSD K.K. | Heart, Parkinson's and Alzheimer's | Mar 26, 2024 | 15 mo later |
| Jun 24, 2025 | WeliregBelzutifan | MSD K.K. | Cancer | Aug 13, 2021 | 46 mo later |
| Jun 24, 2025 | InrebicFedratinib hydrochloride hydrate | Bristol-Myers Squibb K.K. | Cancer | Aug 16, 2019 | 70 mo later |
| Jun 24, 2025 | TalveyTalquetamab (genetical recombination) | Janssen Pharmaceutical K.K. | Cancer | Aug 9, 2023 | 23 mo later |
| May 19, 2025 | mRESVIAmRNA encoding the F glycoprotein from RSV subtype A stabilized in the prefusion conformation | Moderna Japan Co., Ltd. | Vaccines | No US match | — |
| May 19, 2025 | BlenrepBelantamab mafodotin (genetical recombination) | GlaxoSmithKline K.K. | Cancer | Oct 23, 2025 | 5 mo earlier |
| Mar 27, 2025 | LivmarliMaralixibat chloride | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | Sep 29, 2021 | 42 mo later |
| Mar 27, 2025 | BeyonttraAcoramidis hydrochloride | Alexion Pharma GK | Heart, Parkinson's and Alzheimer's | Nov 22, 2024 | 4 mo later |
| Mar 27, 2025 | CamzyosMavacamten | Bristol-Myers Squibb K.K. | Heart, Parkinson's and Alzheimer's | Apr 28, 2022 | 35 mo later |
| Mar 27, 2025 | TevimbraTislelizumab (genetical recombination) | BeiGene Japan GK | Cancer | Mar 13, 2024 | 12 mo later |
| Mar 27, 2025 | LazcluzeLazertinib mesilate hydrate | Janssen Pharmaceutical K.K. | Cancer | Aug 19, 2024 | 7 mo later |
| Mar 27, 2025 | TivdakTisotumab vedotin (genetical recombination) | Genmab K.K. | Cancer | Sep 20, 2021 | 42 mo later |
| Mar 27, 2025 | TibsovoIvosidenib | Nihon Servier Co., Ltd. | Cancer | Jul 20, 2018 | 80 mo later |
| Feb 20, 2025 | Andembry S.C.Garadacimab (genetical recombination) | CSL Behring K.K. | Respiratory and allergy | Jun 16, 2025 | 4 mo earlier |
| Dec 27, 2024 | ZeposiaOzanimod hydrochloride | Bristol-Myers Squibb K.K. | Gastrointestinal, skin and immune | Mar 25, 2020 | 57 mo later |
| Dec 27, 2024 | Tauvid18 F) | PDRadiopharma Inc. | Radiopharmaceuticals | No US match | — |
| Dec 27, 2024 | Qalsody IntrathecalTofersen | Biogen Japan Ltd. | Nervous system | Apr 25, 2023 | 20 mo later |
| Dec 27, 2024 | TepoxxTecovirimat hydrate | Japan Biotechno Pharma Co., Ltd. | Infections | Jul 13, 2018 | 77 mo later |
| Dec 27, 2024 | KavigaleSipavibart (genetical recombination) | AstraZeneca K.K. | Infections | No US match | — |
| Dec 27, 2024 | BrukinsaZanubrutinib | BeiGene Japan GK. | Cancer | Nov 14, 2019 | 61 mo later |
| Dec 27, 2024 | BalversaErdafitinib | Janssen Pharmaceutical K.K. | Cancer | Apr 12, 2019 | 69 mo later |
| Dec 27, 2024 | CalquenceAcalabrutinib maleate hydrate | AstraZeneca K.K. | Cancer | Oct 31, 2017 | 86 mo later |
| Dec 27, 2024 | DatrowayDatopotamab deruxtecan (genetical recombination) | Daiichi Sankyo Company, Limited | Cancer | Jan 17, 2025 | 1 mo earlier |
| Dec 27, 2024 | LunsumioMosunetuzumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | Dec 22, 2022 | 24 mo later |
| Dec 27, 2024 | ImdelltraTarlatamab (genetical recombination) | Amgen K.K. | Cancer | May 16, 2024 | 7 mo later |
| Dec 27, 2024 | TecvayliTeclistamab (genetical recombination) | Janssen Pharmaceutical K.K. | Cancer | Oct 25, 2022 | 26 mo later |
| Dec 27, 2024 | Efluelda intramuscular injectionInfluenza virus (type A and type B) HA fraction | Sanofi K.K. | Vaccines | No US match | — |
| Dec 27, 2024 | HyQviaHuman normal immunoglobulin G (pH4-treated acidic normal human immunoglobulin [subcutaneous injection]) and Vorhyaluronidase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Blood products | No US match | — |
| Dec 27, 2024 | Hympavzi S.C.Marstacimab (genetical recombination) | Pfizer Japan Inc. | Blood products | Oct 11, 2024 | 3 mo later |
| Sep 24, 2024 | VeltassaPatiromer sorbitex calcium | Zeria Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Oct 21, 2015 | 107 mo later |
| Sep 24, 2024 | LupkynisVoclosporin | Otsuka Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jan 22, 2021 | 44 mo later |
| Sep 24, 2024 | TepezzaTeprotumumab (genetical recombination) | Amgen K.K. | Hormones and metabolism | Jan 21, 2020 | 56 mo later |
| Sep 24, 2024 | KisunlaDonanemab (genetical recombination) | Eli Lilly Japan K.K. | Heart, Parkinson's and Alzheimer's | Jul 2, 2024 | 3 mo later |
| Sep 24, 2024 | AlyssaEstetrol hydrate/Drospirenone | Fuji Pharma Co., Ltd. | Reproductive and urinary | No US match | — |
| Sep 24, 2024 | QuviviqDaridorexant hydrochloride | Nexera Pharma Co., Ltd. | Nervous system | Jan 7, 2022 | 33 mo later |
| Sep 24, 2024 | FirdapseAmifampridine phosphate | DyDo Pharma, Inc. | Nervous system | Nov 28, 2018 | 70 mo later |
| Sep 24, 2024 | SeptocaineArticaine hydrochloride/ Adrenaline bitartrate | GC Showayakuhin Corporation | Anesthesia, eye and narcotics | No US match | — |
| Sep 24, 2024 | FruzaqlaFruquintinib | Takeda Pharmaceutical Company Limited | Cancer | Nov 8, 2023 | 11 mo later |
| Sep 24, 2024 | TasfygoTasurgratinib succinate | Eisai Co., Ltd. | Cancer | No US match | — |
| Sep 24, 2024 | AugtyroRepotrectinib | Bristol-Myers Squibb K.K. | Cancer | Nov 15, 2023 | 10 mo later |
| Sep 24, 2024 | RybrevantAmivantamab (genetical recombination) | Janssen Pharmaceutical K.K. | Cancer | May 21, 2021 | 40 mo later |
| Sep 24, 2024 | TrodelvySacituzumab govitecan (genetical recombination) | Gilead Sciences, Inc. | Cancer | Apr 22, 2020 | 53 mo later |
| Sep 24, 2024 | Mearubik IILive attenuated measles virus (Tanabe strain) and live attenuated rubella virus (Matsuura/J16 strain) | The Research Foundation for Microbial Diseases of Osaka University | Vaccines | No US match | — |
| Jun 24, 2024 | FabhaltaIptacopan hydrochloride hydrate | Novartis Pharma K.K. | Gastrointestinal, skin and immune | Dec 5, 2023 | 7 mo later |
| Jun 24, 2024 | VtamaTapinarof | Japan Tobacco Inc. | Gastrointestinal, skin and immune | May 23, 2022 | 25 mo later |
| Jun 24, 2024 | AwiqliInsulin icodec (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Mar 26, 2026 | 21 mo earlier |
| Jun 24, 2024 | BriviactBrivaracetam | UCB Japan Co., Ltd. | Nervous system | Feb 18, 2016 | 100 mo later |
| Jun 24, 2024 | ZaviceftaAvibactam sodium/Ceftazidime hydrate | Pfizer Japan Inc. | Infections | No US match | — |
| Jun 24, 2024 | LivtencityMaribavir | Takeda Pharmaceutical Company Limited | Infections | Nov 23, 2021 | 31 mo later |
| Jun 24, 2024 | JaypircaPirtobrutinib | Eli Lilly Japan K.K. | Cancer | Jan 27, 2023 | 17 mo later |
| Jun 24, 2024 | OmjjaraMomelotinib hydrochloride hydrate | GlaxoSmithKline K.K. | Cancer | Sep 15, 2023 | 9 mo later |
| Jun 24, 2024 | HaiyitanGumarontinib hydrate | Haihe Biopharma K. K. | Cancer | No US match | — |
| Jun 24, 2024 | CovgozeRecombinant coronavirus (SARS- CoV-2) spike protein antigen | Shionogi & Co., Ltd. | Vaccines | No US match | — |
| Jun 24, 2024 | Typhim ViSalmonella typhi (TY2 strain) purified Vi capsular polysaccharide | Sanofi K.K. | Vaccines | No US match | — |
| Mar 26, 2024 | ZintusZinc histidine hydrate | Nobelpharma Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Mar 26, 2024 | PiaskyCrovalimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jun 20, 2024 | 3 mo earlier |
| Mar 26, 2024 | RezurockBelumosudil mesilate | Meiji Seika Pharma Co., Ltd. | Gastrointestinal, skin and immune | Jul 16, 2021 | 32 mo later |
| Mar 26, 2024 | AdzynmaApadamtase alfa (genetical recombination)/ Cinaxadamtase alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Heart, Parkinson's and Alzheimer's | No US match | — |
| Mar 26, 2024 | Acenobel Extended ReleaseAceneuramic acid | Nobelpharma Co., Ltd. | Nervous system | No US match | — |
| Mar 26, 2024 | CystadropsCysteamine hydrochloride | Viatris Pharmaceuticals Japan Inc. | Anesthesia, eye and narcotics | Oct 2, 2012 | 138 mo later |
| Mar 26, 2024 | BeyfortusNirsevimab (genetical recombination) | AstraZeneca K.K. | Infections | Jul 17, 2023 | 8 mo later |
| Mar 26, 2024 | SargmalinSargramostim (genetical recombination) | Nobelpharma Co., Ltd. | Respiratory and allergy | No US match | — |
| Mar 26, 2024 | TruqapCapivasertib | AstraZeneca K.K. | Cancer | Nov 16, 2023 | 4 mo later |
| Mar 26, 2024 | VyloyZolbetuximab (genetical recombination) | Astellas Pharma Inc. | Cancer | Oct 18, 2024 | 7 mo earlier |
| Mar 26, 2024 | Elrexfio S.C.Elranatamab (genetical recombination) | Pfizer Japan Inc. | Cancer | Aug 14, 2023 | 7 mo later |
| Mar 26, 2024 | TicovacInactivated tick-borne encephalitis virus | Pfizer Japan Inc. | Vaccines | No US match | — |
| Mar 26, 2024 | PrevenarPneumococcal polysaccharide conjugated to CRM197 carrier protein | Pfizer Japan Inc. | Vaccines | No US match | — |
| Mar 26, 2024 | CeprotinHuman protein C | Takeda Pharmaceutical Company Limited | Blood products | No US match | — |
| Mar 26, 2024 | ObizurSusoctocog alfa (genetical recombination) | Takeda Pharmaceutical Company Limited | Blood products | No US match | — |
| Mar 5, 2024 | XocovaEnsitrelvir fumaric acid | Shionogi & Co., Ltd. | Infections | No US match | — |
| Jan 18, 2024 | VoydeyaDanicopan | Alexion Pharma GK | Gastrointestinal, skin and immune | Mar 29, 2024 | 2 mo earlier |
| Jan 18, 2024 | ZokinvyLonafarnib | AnGes, Inc. | Hormones and metabolism | Nov 20, 2020 | 38 mo later |
| Jan 18, 2024 | EvkeezaEvinacumab (genetical recombination) | Ultragenyx Japan K.K. | Heart, Parkinson's and Alzheimer's | Feb 11, 2021 | 35 mo later |
| Jan 18, 2024 | VyvduraEfgartigimod alfa (genetical recombination) and Vorhyaluronidase alfa (genetical recombination) | Argenx Japan K.K. | Nervous system | No US match | — |
| Jan 18, 2024 | EbglyssLebrikizumab (genetical recombination) | Eli Lilly Japan K.K. | Respiratory and allergy | Sep 13, 2024 | 8 mo earlier |
| Jan 18, 2024 | TalzennaTalazoparib tosilate | Pfizer Japan Inc. | Cancer | Oct 16, 2018 | 63 mo later |
| Jan 18, 2024 | ReblozylLuspatercept (genetical recombination) | Bristol-Myers Squibb K.K. | Cancer | Apr 3, 2020 | 45 mo later |
| Jan 18, 2024 | AbrysvoRespiratory syncytial virus-A prefusion F protein Respiratory syncytial virus-B prefusion F protein | Pfizer Japan Inc. | Vaccines | No US match | — |
| Nov 30, 2023 | FetrojaCefiderocol tosilate sulfate hydrate | Shionogi & Co., Ltd. | Infections | Nov 14, 2019 | 49 mo later |
| Nov 28, 2023 | KostaiveZapomeran | Meiji Seika Pharma Co., Ltd. | Vaccines | No US match | — |
| Sep 25, 2023 | PhozevelTenapanor hydrochloride | Kyowa Kirin Co., Ltd. | Gastrointestinal, skin and immune | Sep 12, 2019 | 48 mo later |
| Sep 25, 2023 | LeqvioInclisiran sodium | Novartis Pharma K.K. | Heart, Parkinson's and Alzheimer's | Dec 22, 2021 | 21 mo later |
| Sep 25, 2023 | LeqembiLecanemab (genetical recombination) | Eisai Co., Ltd. | Heart, Parkinson's and Alzheimer's | Jan 6, 2023 | 9 mo later |
| Sep 25, 2023 | ZilbrysqZilucoplan sodium | UCB Japan Co., Ltd. | Nervous system | Oct 17, 2023 | 1 mo earlier |
| Sep 25, 2023 | RystiggoRozanolixizumab (genetical recombination) | UCB Japan Co., Ltd. | Nervous system | Jun 26, 2023 | 3 mo later |
| Sep 25, 2023 | Korsuva IVDifelikefalin acetate | Maruishi Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | Aug 23, 2021 | 25 mo later |
| Sep 25, 2023 | PhesgoPertuzumab (genetical recombination), Trastuzumab (genetical recombination), and Vorhyaluronidase alfa (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Sep 25, 2023 | EpkinlyEpcoritamab (genetical recombination) | Genmab K.K. | Cancer | May 19, 2023 | 4 mo later |
| Sep 25, 2023 | Quintovac AqueousProtective antigen of Bordetella pertussis Diphtheria toxoid Tetanus toxoid Inactivated poliovirus types 1-3 (Sabin strain) Haemophilus influenzae type b polysaccharide- tetanus toxoid conjugate | KM Biologics Co., Ltd. | Vaccines | No US match | — |
| Sep 25, 2023 | ArexvyRecombinant respiratory syncytial virus PreF3 antigen | GlaxoSmithKline K.K. | Vaccines | No US match | — |
| Sep 25, 2023 | AlhemoConcizumab (genetical recombination) | Novo Nordisk Pharma Ltd. | Blood products | Dec 20, 2024 | 15 mo earlier |
| Sep 25, 2023 | AltuviiioEfanesoctocog alfa (genetical recombination) | Sanofi K.K. | Blood products | No US match | — |
| Sep 25, 2023 | CuvitruHuman normal immunoglobulin G (pH4-treated acidic normal human immunoglobulin [subcutaneous injection]) | Takeda Pharmaceutical Company, Limited | Blood products | No US match | — |
| Aug 2, 2023 | DaichironaUfrenmeran | Daiichi Sankyo Company, Limited | Vaccines | No US match | — |
| Aug 1, 2023 | SunlencaLenacapavir sodium | Gilead Sciences, Inc. | HIV | Dec 22, 2022 | 7 mo later |
| Jun 26, 2023 | LitfuloRitlecitinib tosilate | Pfizer Japan Inc. | Respiratory and allergy | Jun 23, 2023 | Same month |
| Jun 26, 2023 | OncasparPegaspargase | Nihon Servier Co., Ltd. | Cancer | No US match | — |
| Jun 26, 2023 | Lytgobi tabletsFutibatinib | Taiho Pharmaceutical Co., Ltd. | Cancer | Sep 30, 2022 | 9 mo later |
| Apr 28, 2023 | Mefeego PackMifepristone Misoprostol | Linepharma K.K. | Reproductive and urinary | No US match | — |
| Mar 27, 2023 | EmpaveliPegcetacoplan | Swedish Orphan Biovitrum Japan Co., Ltd. | Gastrointestinal, skin and immune | May 14, 2021 | 22 mo later |
| Mar 27, 2023 | OmvohMirikizumab (genetical recombination) | Eli Lilly Japan K.K. | Gastrointestinal, skin and immune | Oct 26, 2023 | 7 mo earlier |
| Mar 27, 2023 | PalynziqPegvaliase (genetical recombination) | BioMarin Pharmaceutical Japan K.K. | Hormones and metabolism | May 24, 2018 | 58 mo later |
| Mar 27, 2023 | OrphacolCholic acid | ReqMed Company, Ltd. | Hormones and metabolism | Mar 17, 2015 | 96 mo later |
| Mar 27, 2023 | DopteletAvatrombopag maleate | Swedish Orphan Biovitrum Japan Co., Ltd. | Heart, Parkinson's and Alzheimer's | May 21, 2018 | 58 mo later |
| Mar 27, 2023 | BesremiRopeginterferon alfa-2b (genetical recombination) | PharmaEssence Japan K.K. | Cancer | Nov 12, 2021 | 16 mo later |
| Mar 27, 2023 | Fulmist IntranasalLive attenuated influenza virus (type A and type B) | Daiichi Sankyo Company, Limited | Vaccines | No US match | — |
| Mar 27, 2023 | Gobik AqueousProtective antigen of Bordetella pertussis Diphtheria toxoid Tetanus toxoid Inactivated poliovirus types 1-3 (Sabin strain) Haemophilus influenzae type b oligosaccharide - diphtheria CRM 197 conjugate | The Research Foundation for Microbial Diseases of Osaka University | Vaccines | No US match | — |
| Mar 27, 2023 | AtgamAnti-human thymocyte immunoglobulin, equine | Pfizer Japan Inc. | Blood products | No US match | — |
| Dec 23, 2022 | NexoBridPurified pineapple stem juice | Kaken Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Dec 23, 2022 | AllydoneDonepezil | Teikoku Seiyaku Co., Ltd. | Heart, Parkinson's and Alzheimer's | Oct 18, 2004 | 218 mo later |
| Dec 23, 2022 | VyalevFoslevodopa, Foscarbidopa hydrate | AbbVie GK | Heart, Parkinson's and Alzheimer's | No US match | — |
| Dec 23, 2022 | TavalisseFostamatinib sodium hydrate | Kissei Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Apr 17, 2018 | 56 mo later |
| Dec 23, 2022 | CresembaIsavuconazonium sulfate | Asahi Kasei Pharma Corporation | Infections | Mar 6, 2015 | 94 mo later |
| Dec 23, 2022 | Adtralza S.C.Tralokinumab (genetical recombination) | Leo Pharma K.K. | Respiratory and allergy | Dec 27, 2021 | 12 mo later |
| Dec 23, 2022 | ImjudoTremelimumab (genetical recombination) | AstraZeneca K.K. | Cancer | Oct 21, 2022 | 2 mo later |
| Dec 23, 2022 | LibtayoCemiplimab (genetical recombination) | Sanofi K.K. | Cancer | Sep 28, 2018 | 51 mo later |
| Nov 22, 2022 | XocovaEnsitrelvir fumaric acid | Shionogi & Co., Ltd. | Infections | No US match | — |
| Sep 26, 2022 | MounjaroTirzepatide | Eli Lilly Japan K.K. | Hormones and metabolism | May 13, 2022 | 4 mo later |
| Sep 26, 2022 | CabliviCaplacizumab (genetical recombination) | Sanofi K.K. | Heart, Parkinson's and Alzheimer's | Feb 6, 2019 | 44 mo later |
| Sep 26, 2022 | KoselugoSelumetinib sulfate | Alexion Pharma GK | Nervous system | Apr 10, 2020 | 30 mo later |
| Sep 26, 2022 | AmvuttraVutrisiran sodium | Alnylam Japan, K.K. | Nervous system | Jun 13, 2022 | 3 mo later |
| Sep 26, 2022 | FinteplaFenfluramine hydrochloride | UCB Japan Co., Ltd. | Nervous system | Jun 25, 2020 | 27 mo later |
| Sep 26, 2022 | NanozoraOzoralizumab (genetical recombination) | Taisho Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 26, 2022 | SpevigoSpesolimab (genetical recombination) | Nippon Boehringer Ingelheim Co., Ltd. | Respiratory and allergy | Sep 1, 2022 | 1 mo later |
| Sep 26, 2022 | TezspireTezepelumab (genetical recombination) | AstraZeneca K.K. | Respiratory and allergy | Dec 17, 2021 | 9 mo later |
| Sep 26, 2022 | SotyktuDeucravacitinib | Bristol-Myers Squibb K.K. | Respiratory and allergy | Sep 9, 2022 | 1 mo later |
| Sep 26, 2022 | EzharmiaValemetostat tosilate | Daiichi Sankyo Company, Limited | Cancer | No US match | — |
| Sep 26, 2022 | MenQuadfi intramuscular injectionNeisseria meningitidis polysaccharides conjugated to tetanus toxoid (serogroups A, C, W, and Y) | Sanofi K.K. | Vaccines | No US match | — |
| Sep 26, 2022 | Vaxneuvance AqueousPneumococcal polysaccharides of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F conjugated to CRM197 carrier protein | MSD K.K. | Vaccines | No US match | — |
| Aug 30, 2022 | EvusheldTixagevimab (genetical recombination), Cilgavimab (genetical recombination) | AstraZeneca K.K. | Infections | No US match | — |
| Jun 20, 2022 | EnjaymoSutimlimab (genetical recombination) | Sanofi K.K. | Gastrointestinal, skin and immune | Feb 4, 2022 | 4 mo later |
| Jun 20, 2022 | VoxzogoVosoritide (genetical recombination) | BioMarin Pharmaceutical K.K. | Hormones and metabolism | Nov 19, 2021 | 7 mo later |
| Jun 20, 2022 | DarviasDarinaparsin | Solasia Pharma K.K. | Cancer | No US match | — |
| Jun 20, 2022 | JeselhyPimitespib | Taiho Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Jun 20, 2022 | JcovdenCOVID-19 (SARS-CoV- 2) vaccine (recombinant adenovirus vector) | Janssen Pharmaceutical K.K. | Vaccines | No US match | — |
| May 31, 2022 | 1) Vocabria Aqueous1) 2) Cabotegravir 3) Cabotegravir sodium 4) 5) Rilpivirine | Not listed | HIV | No US match | — |
| Apr 19, 2022 | NuvaxovidRecombinant coronavirus (SARS- CoV-2) vaccine | Takeda Pharmaceutical Company Limited | Vaccines | No US match | — |
| Mar 28, 2022 | ArokarisFosnetupitant chloride hydrochloride | Taiho Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Mar 28, 2022 | MonoVerFerric derisomaltose | Nippon Shinyaku Co., Ltd. | Gastrointestinal, skin and immune | Jan 16, 2020 | 26 mo later |
| Mar 28, 2022 | CarograCarotegrast methyl | EA Pharma Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Mar 28, 2022 | XenpozymeOlipudase alfa (genetical recombination) | Sanofi K.K. | Hormones and metabolism | Aug 31, 2022 | 5 mo earlier |
| Mar 28, 2022 | OndexxyaAndexanet alfa (genetical recombination) | Alexion Pharma G.K. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Mar 28, 2022 | KerendiaFinerenone | Bayer Yakuhin, Ltd. | Heart, Parkinson's and Alzheimer's | Jul 9, 2021 | 9 mo later |
| Mar 28, 2022 | SamtasuTolvaptan sodium phosphate | Otsuka Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | May 19, 2009 | 154 mo later |
| Mar 28, 2022 | DysvalValbenazine tosilate | Mitsubishi Tanabe Pharma Corporation | Nervous system | Apr 11, 2017 | 60 mo later |
| Mar 28, 2022 | VabysmoFaricimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | Jan 28, 2022 | 2 mo later |
| Mar 28, 2022 | MitchgaNemolizumab (genetical recombination) | Maruho Co., Ltd. | Respiratory and allergy | Aug 12, 2024 | 29 mo earlier |
| Mar 28, 2022 | TakhzyroLanadelumab (genetical recombination) | Takeda Pharmaceutical Company Limited | Respiratory and allergy | Aug 23, 2018 | 43 mo later |
| Mar 28, 2022 | ScemblixAsciminib hydrochloride | Novartis Pharma K.K. | Cancer | Oct 29, 2021 | 5 mo later |
| Feb 10, 2022 | PaxlovidpackNirmatrelvir/Ritonavir | Pfizer Japan Inc. | Infections | No US match | — |
| Jan 20, 2022 | Rapifort WipesGlycopyrronium tosilate hydrate | Maruho Co., Ltd. | Gastrointestinal, skin and immune | Jun 28, 2018 | 43 mo later |
| Jan 20, 2022 | MepseviiVestronidase alfa (genetical recombination) | Amicus Therapeutics, Inc. | Hormones and metabolism | Nov 15, 2017 | 50 mo later |
| Jan 20, 2022 | NgenlaSomatrogon (genetical recombination) | Pfizer Japan Inc. | Hormones and metabolism | Jun 27, 2023 | 17 mo earlier |
| Jan 20, 2022 | ReyvowLasmiditan succinate | Eli Lilly Japan K.K. | Heart, Parkinson's and Alzheimer's | Oct 11, 2019 | 27 mo later |
| Jan 20, 2022 | PivlazClazosentan sodium | Idorsia Pharmaceuticals Japan Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 20, 2022 | VyvgartEfgartigimod alfa (genetical recombination) | Argenx Japan K.K. | Nervous system | Dec 17, 2021 | 1 mo later |
| Jan 20, 2022 | LyfnuaGefapixant citrate | MSD K.K. | Respiratory and allergy | No US match | — |
| Jan 20, 2022 | BimzelxBimekizumab (genetical recombination) | UCB Japan Co., Ltd. | Respiratory and allergy | Oct 17, 2023 | 21 mo earlier |
| Jan 20, 2022 | LumakrasSotorasib | Amgen K.K. | Cancer | May 28, 2021 | 8 mo later |
| Dec 24, 2021 | LagevrioMolnupiravir | MSD K.K. | Infections | No US match | — |
| Sep 27, 2021 | MoizertoDifamilast | Otsuka Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Feb 12, 2026 | 53 mo earlier |
| Sep 27, 2021 | NexviazymeAvalglucosidase alfa (genetical recombination) | Sanofi K.K. | Hormones and metabolism | Aug 6, 2021 | 2 mo later |
| Sep 27, 2021 | VynmacTafamidis | Pfizer Japan Inc. | Heart, Parkinson's and Alzheimer's | May 3, 2019 | 29 mo later |
| Sep 27, 2021 | XevudySotrovimab (genetical recombination) | GlaxoSmithKline K.K. | Infections | No US match | — |
| Sep 27, 2021 | CibinqoAbrocitinib | Pfizer Japan Inc. | Respiratory and allergy | Jan 14, 2022 | 4 mo earlier |
| Sep 27, 2021 | SaphneloAnifrolumab (genetical recombination) | AstraZeneca K.K. | Respiratory and allergy | Jul 30, 2021 | 2 mo later |
| Sep 27, 2021 | TavneosAvacopan | Kissei Pharmaceutical Co., Ltd. | Respiratory and allergy | Oct 7, 2021 | Same month |
| Sep 27, 2021 | RetevmoSelpercatinib | Eli Lilly Japan K.K. | Cancer | May 8, 2020 | 17 mo later |
| Sep 27, 2021 | Raiatt MIBG-I3-Iodobenzylguanidine 131 ( I) | Fujifilm Toyama Chemical Co., Ltd. | Cancer | No US match | — |
| Sep 27, 2021 | PadcevEnfortumab vedotin (genetical recombination) | Astellas Pharma Inc. | Cancer | Dec 18, 2019 | 21 mo later |
| Sep 27, 2021 | MegludaseGlucarpidase (genetical recombination) | Ohara Pharmaceutical Co., Ltd. | Cancer | Jan 17, 2012 | 116 mo later |
| Jul 19, 2021 | RonapreveCasirivimab (genetical recombination), Imdevimab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Infections | No US match | — |
| Jun 23, 2021 | Upasita IVUpacicalcet sodium hydrate | Sanwa Kagaku Kenkyusho Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Jun 23, 2021 | RevestiveTeduglutide (genetical recombination) | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | Dec 21, 2012 | 102 mo later |
| Jun 23, 2021 | TwymeegImeglimin hydrochloride | Sumitomo Dainippon Pharma Co., Ltd. | Hormones and metabolism | No US match | — |
| Jun 23, 2021 | GivlaariGivosiran sodium | Alnylam Japan K.K. | Hormones and metabolism | Nov 20, 2019 | 19 mo later |
| Jun 23, 2021 | VerquvoVericiguat | Bayer Yakuhin, Ltd. | Heart, Parkinson's and Alzheimer's | Jan 19, 2021 | 5 mo later |
| Jun 23, 2021 | AjovyFremanezumab (genetical recombination) | Otsuka Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Sep 14, 2018 | 33 mo later |
| Jun 23, 2021 | AimovigErenumab (genetical recombination) | Amgen K.K. | Heart, Parkinson's and Alzheimer's | May 17, 2018 | 37 mo later |
| Jun 23, 2021 | EvrysdiRisdiplam | Chugai Pharmaceutical Co., Ltd. | Nervous system | Aug 7, 2020 | 11 mo later |
| Jun 23, 2021 | RecarbrioRelebactam hydrate/Imipenem hydrate/Cilastatin sodium | MSD K.K. | Infections | No US match | — |
| Jun 23, 2021 | TazverikTazemetostat hydrobromide | Eisai Co., Ltd. | Cancer | Jan 23, 2020 | 17 mo later |
| Jun 23, 2021 | LutatheraLutetium ( 177 Lu) oxodotreotide | Fujifilm Toyama Chemical Co., Ltd. | Cancer | No US match | — |
| Jun 23, 2021 | UnituxinDinutuximab (genetical recombination) | Ohara Pharmaceutical Co.,Ltd. | Cancer | Mar 10, 2015 | 75 mo later |
| Jun 23, 2021 | HiyastaTucidinostat | Huya Japan G.K. | Cancer | No US match | — |
| May 21, 2021 | COVID-19 Vaccine ModernaCX-024414 | Takeda Pharmaceutical Company Limited | Vaccines | No US match | — |
| May 21, 2021 | VaxzevriaCOVID-19 (SARS- CoV-2) vaccine (recombinant chimpanzee adenovirus vector) Tozinameran | Pfizer Japan Inc. | Vaccines | No US match | — |
| Mar 23, 2021 | IsturisaOsilodrostat phosphate | Recordati Rare Diseases Japan K.K. | Hormones and metabolism | Mar 6, 2020 | 13 mo later |
| Mar 23, 2021 | OstabaloAbaloparatide acetate | Teijin Pharma Limited | Hormones and metabolism | Apr 28, 2017 | 47 mo later |
| Mar 23, 2021 | IzcargoPabinafusp alfa (genetical recombination) | JCR Pharmaceuticals Co., Ltd. | Hormones and metabolism | No US match | — |
| Mar 23, 2021 | RekovelleFollitropin delta (genetical recombination) | Ferring Pharmaceuticals Co., Ltd. | Reproductive and urinary | No US match | — |
| Mar 23, 2021 | AxuminFluciclovine ( 18 F) | Nihon Medi-Physics Co., Ltd. | Radiopharmaceuticals | No US match | — |
| Mar 23, 2021 | UpliznaInebilizumab (genetical recombination) | Mitsubishi Tanabe Pharma Corporation | Nervous system | Jun 11, 2020 | 9 mo later |
| Mar 23, 2021 | JoycluDiclofenac etalhyaluronate sodium | Seikagaku Corporation | Respiratory and allergy | No US match | — |
| Mar 23, 2021 | RemitoroDenileukin diftitox (genetical recombination) | Eisai Co., Ltd. | Cancer | Feb 5, 1999 | 266 mo later |
| Mar 23, 2021 | VitrakviLarotrectinib sulfate | Bayer Yakuhin, Ltd. | Cancer | Nov 26, 2018 | 28 mo later |
| Mar 23, 2021 | DarzquroDaratumumab (genetical recombination)/ Vorhyaluronidase alfa (genetical recombination) | Janssen Pharmaceutical K.K. | Cancer | No US match | — |
| Mar 23, 2021 | PolivyPolatuzumab vedotin (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | Jun 10, 2019 | 21 mo later |
| Mar 23, 2021 | PemazyrePemigatinib | Incyte Biosciences Japan GK | Cancer | Apr 17, 2020 | 11 mo later |
| Feb 14, 2021 | Comirnaty intramuscular injectionTozinameran | Pfizer Japan Inc. | Vaccines | No US match | — |
| Jan 22, 2021 | MusredoMolidustat sodium | Bayer Yakuhin, Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Jan 22, 2021 | AdlumizAnamorelin hydrochloride | Ono Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Jan 22, 2021 | SogroyaSomapacitan (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Aug 28, 2020 | 5 mo later |
| Jan 22, 2021 | Hunterase ICVIdursulfase beta (genetical recombination) | Clinigen K.K. | Hormones and metabolism | No US match | — |
| Jan 22, 2021 | EmgalityGalcanezumab (genetical recombination) | Eli Lilly Japan K.K. | Heart, Parkinson's and Alzheimer's | Sep 27, 2018 | 28 mo later |
| Jan 22, 2021 | Zymso IntravesicalDimethyl sulfoxide | Kyorin Pharmaceutical Co., Ltd. | Reproductive and urinary | No US match | — |
| Jan 22, 2021 | OrladeyoBerotralstat hydrochloride | OrphanPacific, Inc. | Respiratory and allergy | Dec 3, 2020 | 2 mo later |
| Jan 22, 2021 | CalquenceAcalabrutinib | AstraZeneca K.K. | Cancer | Oct 31, 2017 | 39 mo later |
| Jan 22, 2021 | AlunbrigBrigatinib | Takeda Pharmaceutical Company Limited | Cancer | Apr 28, 2017 | 45 mo later |
| Jan 22, 2021 | NuwiqSimoctocog alfa (genetical recombination) | Fujimoto Pharmaceutical Corporation | Blood products | No US match | — |
| Jan 22, 2021 | LynspadLyophilized human alpha1-proteinase inhibitor concentrate | Grifols Therapeutics LLC | Blood products | No US match | — |
| Sep 25, 2020 | EcclockSofpironium bromide | Kaken Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jun 18, 2024 | 45 mo earlier |
| Sep 25, 2020 | EnaroyEnarodustat | Japan Tobacco Inc. | Gastrointestinal, skin and immune | No US match | — |
| Sep 25, 2020 | JyselecaFilgotinib maleate | Gilead Sciences K.K. | Respiratory and allergy | No US match | — |
| Sep 25, 2020 | ZejulaNiraparib tosilate hydrate | Takeda Pharmaceutical Company Limited | Cancer | Mar 27, 2017 | 42 mo later |
| Sep 25, 2020 | Akalux IVCetuximab sarotalocan sodium (genetical recombination) | Rakuten Medical Japan K.K. | Cancer | No US match | — |
| Jul 21, 2020 | Silgard9 AqueousRecombinant adsorbed 9-valent human papillomavirus virus-like particle vaccine (yeast origin) | MSD K.K. | Vaccines | No US match | — |
| Jun 29, 2020 | VafseoVadadustat | Mitsubishi Tanabe Pharma Corporation | Gastrointestinal, skin and immune | Mar 27, 2024 | 45 mo earlier |
| Jun 29, 2020 | DuvroqDaprodustat | GlaxoSmithKline K.K. | Gastrointestinal, skin and immune | Feb 1, 2023 | 31 mo earlier |
| Jun 29, 2020 | EntrestoSacubitril valsartan sodium hydrate | Novartis Pharma K.K. | Heart, Parkinson's and Alzheimer's | Jul 7, 2015 | 60 mo later |
| Jun 29, 2020 | OngentysOpicapone | Ono Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Apr 24, 2020 | 2 mo later |
| Jun 29, 2020 | MayzentSiponimod fumaric acid | Novartis Pharma K.K. | Nervous system | No US match | — |
| Jun 29, 2020 | XeominIncobotulinumtoxin A | Teijin Pharma Limited | Nervous system | No US match | — |
| Jun 29, 2020 | EnspryngSatralizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Nervous system | Aug 14, 2020 | 2 mo earlier |
| Jun 29, 2020 | IlumyaTildrakizumab (genetical recombination) | Sun Pharma Japan Ltd. | Respiratory and allergy | Mar 20, 2018 | 27 mo later |
| Jun 29, 2020 | AtecturaIndacaterol acetate/Mometasone furoate | Novartis Pharma K.K. | Respiratory and allergy | No US match | — |
| Jun 29, 2020 | EnerzairIndacaterol acetate/Glycopyrronium bromide/Mometasone furoate | Novartis Pharma K.K. | Respiratory and allergy | No US match | — |
| Jun 29, 2020 | SarclisaIsatuximab (genetical recombination) | Sanofi K.K. | Cancer | Mar 2, 2020 | 4 mo later |
| Jun 29, 2020 | TabrectaCapmatinib hydrochloride hydrate | Novartis Pharma K.K. | Cancer | May 6, 2020 | 2 mo later |
| May 7, 2020 | VekluryRemdesivir | Gilead Sciences K.K. | Infections | Oct 22, 2020 | 6 mo earlier |
| Mar 25, 2020 | LokelmaSodium zirconium cyclosilicate hydrate | AstraZeneca K.K. | Gastrointestinal, skin and immune | May 18, 2018 | 22 mo later |
| Mar 25, 2020 | MelatobelMelatonin | Nobelpharma Co., Ltd. | Nervous system | No US match | — |
| Mar 25, 2020 | LatudaLurasidone hydrochloride | Sumitomo Dainippon Pharma Co., Ltd. | Nervous system | Oct 28, 2010 | 113 mo later |
| Mar 25, 2020 | ViltepsoViltolarsen | Nippon Shinyaku Co., Ltd. | Nervous system | Aug 12, 2020 | 5 mo earlier |
| Mar 25, 2020 | BeovuBrolucizumab (genetical recombination) | Novartis Pharma K.K. | Anesthesia, eye and narcotics | Oct 7, 2019 | 6 mo later |
| Mar 25, 2020 | CabometyxCabozantinib malate | Takeda Pharmaceutical Company Limited | Cancer | No US match | — |
| Mar 25, 2020 | VelexbruTirabrutinib hydrochloride | Ono Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Mar 25, 2020 | EnhertuTrastuzumab deruxtecan (genetical recombination) | Daiichi Sankyo Company, Limited | Cancer | No US match | — |
| Mar 25, 2020 | Steboronine10 B) | Stella Pharma Corporation | Cancer | No US match | — |
| Mar 25, 2020 | TepmetkoTepotinib hydrochloride hydrate | Merck Biopharma Co., Ltd. | Cancer | Feb 3, 2021 | 10 mo earlier |
| Mar 25, 2020 | VonvendiVonicog alfa (genetical recombination) | Shire Japan K.K. | Blood products | No US match | — |
| Jan 23, 2020 | CorectimDelgocitinib | Japan Tobacco Inc. | Gastrointestinal, skin and immune | Jul 23, 2025 | 66 mo earlier |
| Jan 23, 2020 | UreceDotinurad | Fuji Yakuhin Co., Ltd. | Hormones and metabolism | No US match | — |
| Jan 23, 2020 | DayvigoLemborexant | Eisai Co., Ltd. | Nervous system | Dec 20, 2019 | 1 mo later |
| Jan 23, 2020 | AneremRemimazolam besilate | Mundipharma K.K. | Anesthesia, eye and narcotics | Jul 2, 2020 | 5 mo earlier |
| Jan 23, 2020 | NoxafilPosaconazole | MSD K.K. | Infections | Sep 15, 2006 | 160 mo later |
| Jan 23, 2020 | RinvoqUpadacitinib hydrate | AbbVie GK | Respiratory and allergy | Aug 16, 2019 | 5 mo later |
| Jan 23, 2020 | NubeqaDarolutamide | Bayer Yakuhin, Ltd. | Cancer | Jul 30, 2019 | 6 mo later |
| Jan 14, 2020 | PifeltroDoravirine | MSD K.K. | HIV | Aug 30, 2018 | 16 mo later |
| Sep 20, 2019 | EvrenzoRoxadustat | Astellas Pharma Inc. | Gastrointestinal, skin and immune | No US match | — |
| Sep 20, 2019 | Brineura Intracerebroventricular InjectableCerliponase alfa (genetical recombination) | BioMarin Pharmaceutical Japan K.K. | Hormones and metabolism | Apr 27, 2017 | 29 mo later |
| Sep 20, 2019 | CrysvitaBurosumab (genetical recombination) | Kyowa Kirin Co., Ltd. | Hormones and metabolism | Apr 17, 2018 | 17 mo later |
| Sep 20, 2019 | EqufinaSafinamide mesilate | Meiji Seika Pharma Co., Ltd. | Heart, Parkinson's and Alzheimer's | Mar 21, 2017 | 30 mo later |
| Sep 20, 2019 | CoralanIvabradine hydrochloride | Ono Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Apr 15, 2015 | 53 mo later |
| Sep 20, 2019 | TrintellixVortioxetine hydrobromide | Takeda Pharmaceutical Company Limited | Nervous system | Sep 30, 2013 | 72 mo later |
| Sep 20, 2019 | LasvicLascufloxacin hydrochloride | Kyorin Pharmaceutical Co., Ltd. | Infections | No US match | — |
| Sep 20, 2019 | VenclextaVenetoclax | AbbVie GK | Cancer | Apr 11, 2016 | 41 mo later |
| Sep 20, 2019 | EsperoctTuroctocog alfa pegol (genetical recombination) | Novo Nordisk Pharma Ltd. | Blood products | No US match | — |
| Jun 18, 2019 | UltomirisRavulizumab (genetical recombination) | Alexion Pharma G.K. | Gastrointestinal, skin and immune | Dec 21, 2018 | 6 mo later |
| Jun 18, 2019 | DefitelioDefibrotide sodium | Nippon Shinyaku Co., Ltd. | Heart, Parkinson's and Alzheimer's | Mar 30, 2016 | 39 mo later |
| Jun 18, 2019 | OnpattroPatisiran sodium | Alnylam Japan K.K. | Nervous system | Aug 10, 2018 | 10 mo later |
| Jun 18, 2019 | Breztri AerosphereBudesonide /Glycopyrronium bromide/Formoterol fumarate hydrate | AstraZeneca K.K. | Respiratory and allergy | No US match | — |
| Jun 18, 2019 | Bevespi AerosphereGlycopyrronium bromide/Formoterol fumarate hydrate | AstraZeneca K.K. | Respiratory and allergy | No US match | — |
| Jun 18, 2019 | PortrazzaNecitumumab (genetical recombination) | Eli Lilly Japan K.K. | Cancer | Nov 24, 2015 | 43 mo later |
| Jun 18, 2019 | VanflytaQuizartinib hydrochloride | Daiichi Sankyo Company, Limited | Cancer | Jul 20, 2023 | 49 mo earlier |
| Jun 18, 2019 | RozlytrekEntrectinib | Chugai Pharmaceutical Co., Ltd. | Cancer | Aug 15, 2019 | 2 mo earlier |
| Mar 26, 2019 | FerinjectFerric carboxymaltose | Zeria Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jul 25, 2013 | 68 mo later |
| Mar 26, 2019 | AselendSodium selenite | Fujimoto Pharmaceutical Corporation | Gastrointestinal, skin and immune | No US match | — |
| Mar 26, 2019 | VyvanseLisdexamfetamine mesilate | Shionogi & Co., Ltd. | Nervous system | No US match | — |
| Mar 26, 2019 | PrivigenpH4-treated acidic normal human immunoglobulin | CSL Behring K.K. | Nervous system | No US match | — |
| Mar 26, 2019 | SkyriziRisankizumab (genetical recombination) | AbbVie GK | Respiratory and allergy | Apr 23, 2019 | 1 mo earlier |
| Mar 26, 2019 | SmyrafPeficitinib hydrobromide | Astellas Pharma Inc. | Respiratory and allergy | No US match | — |
| Mar 26, 2019 | RevcoviElapegademase (genetical recombination) | Teijin Pharma Limited | Hormones and metabolism | Oct 5, 2018 | 6 mo later |
| Mar 26, 2019 | ErleadaApalutamide | Janssen Pharmaceutical K.K. | Cancer | Feb 14, 2018 | 13 mo later |
| Mar 26, 2019 | RethioThiotepa | Sumitomo Dainippon Pharma Co., Ltd. | Cancer | Jan 26, 2017 | 26 mo later |
| Mar 26, 2019 | BiktarvyBictegravir sodium/ Emtricitabine/Tenofovir alafenamide fumarate | Gilead Sciences K.K. | HIV | No US match | — |
| Mar 26, 2019 | RabipurFreeze-dried inactivated tissue culture rabies vaccine | GlaxoSmithKline K.K. | Vaccines | No US match | — |
| Jan 8, 2019 | MinnebroEsaxerenone | Daiichi Sankyo Company, Limited | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 8, 2019 | DemserMetirosine | Ono Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 8, 2019 | SelincroNalmefene hydrochloride hydrate | Otsuka Pharmaceutical Co., Ltd. | Nervous system | May 22, 2023 | 52 mo earlier |
| Jan 8, 2019 | TarligeMirogabalin besilate | Daiichi Sankyo Company, Limited | Nervous system | No US match | — |
| Jan 8, 2019 | ZerbaxaCeftolozane sulfate/Tazobactam sodium | MSD K.K. | Infections | No US match | — |
| Jan 8, 2019 | EpclusaSofosbuvir/Velpatasvir | Gilead Sciences K.K. | Infections | No US match | — |
| Jan 8, 2019 | ReluminaRelugolix | Takeda Pharmaceutical Company Limited | Reproductive and urinary | Dec 18, 2020 | 23 mo earlier |
| Jan 8, 2019 | EvenityRomosozumab (genetical recombination) | Amgen Astellas BioPharma K.K. | Hormones and metabolism | Apr 9, 2019 | 3 mo earlier |
| Jan 8, 2019 | BraftoviEncorafenib | Ono Pharmaceutical Co., Ltd. | Cancer | Jun 27, 2018 | 6 mo later |
| Jan 8, 2019 | MektoviBinimetinib | Ono Pharmaceutical Co., Ltd. | Cancer | Jun 27, 2018 | 6 mo later |
| Jan 8, 2019 | VizimproDacomitinib hydrate | Pfizer Japan Inc. | Cancer | Sep 27, 2018 | 3 mo later |
| Nov 26, 2018 | JulucaDolutegravir sodium/Rilpivirine hydrochloride | ViiV Healthcare K.K. | HIV | No US match | — |
| Sep 21, 2018 | EybelisOmidenepag isopropyl | Santen Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | Sep 22, 2022 | 48 mo earlier |
| Sep 21, 2018 | BeovaVibegron | Kyorin Pharmaceutical Co., Ltd. | Reproductive and urinary | Dec 23, 2020 | 27 mo earlier |
| Sep 21, 2018 | FirazyrIcatibant acetate | Shire Japan KK | Respiratory and allergy | Aug 25, 2011 | 85 mo later |
| Sep 21, 2018 | VerzenioAbemaciclib | Eli Lilly Japan K.K. | Cancer | Sep 28, 2017 | 12 mo later |
| Sep 21, 2018 | BlincytoBlinatumomab (genetical recombination) | Amgen Astellas BioPharma K.K. | Cancer | Dec 3, 2014 | 46 mo later |
| Sep 21, 2018 | LorbrenaLorlatinib | Pfizer Japan Inc. | Cancer | Nov 2, 2018 | 1 mo earlier |
| Sep 21, 2018 | XospataGilteritinib fumarate | Astellas Pharma Inc. | Cancer | Nov 28, 2018 | 2 mo earlier |
| Sep 21, 2018 | JiviDamoctocog alfa pegol (genetical recombination) | Bayer Yakuhin, Ltd. | Blood products | No US match | — |
| Aug 21, 2018 | OdefseyRilpivirine hydrochloride /Emtricitabine/Tenofovir alafenamide fumarate | Janssen Pharmaceutical K.K. | HIV | No US match | — |
| Jul 2, 2018 | EntyvioVedolizumab (genetical recombination) | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | May 20, 2014 | 49 mo later |
| Jul 2, 2018 | DafclirFidaxomicin | Astellas Pharma Inc. | Infections | May 27, 2011 | 85 mo later |
| Jul 2, 2018 | SpiramycinSpiramycin Valganciclovir hydrochloride | Mitsubishi Tanabe Pharma Corporation | Infections | No US match | — |
| Jul 2, 2018 | ImfinziDurvalumab (genetical recombination) | AstraZeneca K.K. | Cancer | May 1, 2017 | 14 mo later |
| Jul 2, 2018 | GazyvaObinutuzumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | Nov 1, 2013 | 56 mo later |
| Jul 2, 2018 | RefixiaNonacog beta pegol (genetical recombination) | Novo Nordisk Pharma Ltd. | Blood products | No US match | — |
| Mar 23, 2018 | OrkediaEvocalcet | Kyowa Hakko Kirin Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Mar 23, 2018 | AzilectRasagiline mesilate | Takeda Pharmaceutical Company Limited | Heart, Parkinson's and Alzheimer's | May 16, 2006 | 142 mo later |
| Mar 23, 2018 | HernicoreCondoliase | Seikagaku Corporation | Nervous system | No US match | — |
| Mar 23, 2018 | SivextroTedizolid phosphate | Bayer Yakuhin, Ltd. | Infections | Jun 20, 2014 | 45 mo later |
| Mar 23, 2018 | PrevymisLetermovir | MSD K.K. | Infections | Nov 8, 2017 | 4 mo later |
| Mar 23, 2018 | TremfyaGuselkumab (genetical recombination) | Janssen Pharmaceutical K.K. | Respiratory and allergy | Jul 13, 2017 | 8 mo later |
| Mar 23, 2018 | OzempicSemaglutide (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Dec 5, 2017 | 4 mo later |
| Mar 23, 2018 | GalafoldMigalastat hydrochloride | Amicus Therapeutics, Inc. | Hormones and metabolism | Aug 10, 2018 | 5 mo earlier |
| Mar 23, 2018 | ShingrixFreeze-dried recombinant herpes zoster vaccine (prepared from Chinese hamster ovary cells) | Japan Vaccine Co., Ltd. | Vaccines | No US match | — |
| Mar 23, 2018 | Hemlibra s.c.Emicizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Blood products | Nov 16, 2017 | 4 mo later |
| Feb 23, 2018 | XofluzaBaloxavir marboxil | Shionogi & Co., Ltd. | Infections | Oct 24, 2018 | 8 mo earlier |
| Jan 19, 2018 | GooficeElobixibat hydrate | EA Pharma Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Jan 19, 2018 | IbuliefIbuprofen L-lysine | Senju Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 19, 2018 | RexultiBrexpiprazole | Otsuka Pharmaceutical Co., Ltd. | Nervous system | Jul 10, 2015 | 30 mo later |
| Jan 19, 2018 | NailinFosravuconazole L- lysine ethanolate | Sato Pharmaceutical Co., Ltd. | Infections | No US match | — |
| Jan 19, 2018 | SirturoBedaquiline fumarate | Janssen Pharmaceutical K.K. | Infections | Dec 28, 2012 | 61 mo later |
| Jan 19, 2018 | DupixentDupilumab (genetical recombination) | Sanofi K.K. | Respiratory and allergy | Mar 28, 2017 | 10 mo later |
| Jan 19, 2018 | FasenraBenralizumab (genetical recombination) | AstraZeneca K.K. | Respiratory and allergy | Nov 14, 2017 | 2 mo later |
| Jan 19, 2018 | TecentriqAtezolizumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | May 18, 2016 | 20 mo later |
| Jan 19, 2018 | BesponsaInotuzumab ozogamicin (genetical recombination) | Pfizer Japan Inc. | Cancer | Aug 17, 2017 | 5 mo later |
| Jan 19, 2018 | LynparzaOlaparib | AstraZeneca K.K. | Cancer | Dec 19, 2014 | 37 mo later |
| Sep 27, 2017 | ZinplavaBezlotoxumab (genetical recombination) | MSD K.K. | Infections | Oct 21, 2016 | 11 mo later |
| Sep 27, 2017 | MaviretGlecaprevir hydrate/ Pibrentasvir | AbbVie GK | Infections | No US match | — |
| Sep 27, 2017 | Cedarcure Japanese Cedar Pollen SublingualJapanese cedar pollen extract bulk powder | Torii Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 27, 2017 | KevzaraSarilumab (genetical recombination) | Sanofi K.K. | Respiratory and allergy | May 22, 2017 | 4 mo later |
| Sep 27, 2017 | RupafinRupatadine fumarate | Teikoku Seiyaku Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 27, 2017 | BenlystaBelimumab (genetical recombination) | GlaxoSmithKline K.K. | Respiratory and allergy | Mar 9, 2011 | 79 mo later |
| Sep 27, 2017 | VizamylFlutemetamol (18F) | Nihon Medi-Physics Co., Ltd. | Radiopharmaceuticals | No US match | — |
| Sep 27, 2017 | IbrancePalbociclib | Pfizer Japan Inc. | Cancer | Feb 3, 2015 | 32 mo later |
| Sep 27, 2017 | DarzalexDaratumumab (genetical recombination) | Janssen Pharmaceutical K.K. | Cancer | Nov 16, 2015 | 22 mo later |
| Sep 27, 2017 | BavencioAvelumab (genetical recombination) | Merck Serono Co., Ltd. | Cancer | Mar 23, 2017 | 6 mo later |
| Sep 27, 2017 | AfstylaLonoctocog alfa (genetical recombination) | CSL Behring K.K. | Blood products | No US match | — |
| Jul 3, 2017 | ParmodiaPemafibrate | Kowa Company, Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jul 3, 2017 | Spinraza Intrathecal injectionNusinersen sodium | Biogen Japan Ltd. | Nervous system | Dec 23, 2016 | 6 mo later |
| Jul 3, 2017 | AmenaliefAmenamevir | Maruho Co., Ltd. | Infections | No US match | — |
| Jul 3, 2017 | OlumiantBaricitinib | Eli Lilly Japan K.K. | Respiratory and allergy | May 31, 2018 | 11 mo earlier |
| Jul 3, 2017 | DifoltaPralatrexate | Mundipharma K.K. | Cancer | Sep 24, 2009 | 93 mo later |
| Jul 3, 2017 | IstodaxRomidepsin | Celgene K.K. | Cancer | Nov 5, 2009 | 92 mo later |
| Mar 30, 2017 | SymproicNaldemedine tosilate | Shionogi & Co., Ltd. | Gastrointestinal, skin and immune | Mar 23, 2017 | Same month |
| Mar 30, 2017 | IntunivGuanfacine hydrochloride | Shionogi & Co., Ltd. | Nervous system | Sep 2, 2009 | 91 mo later |
| Mar 30, 2017 | NarususHydromorphone hydrochloride | Daiichi Sankyo Propharma Co., Ltd. | Anesthesia, eye and narcotics | Sep 24, 2004 | 150 mo later |
| Mar 30, 2017 | ZaltrapAflibercept beta (genetical recombination) | Sanofi K.K. | Cancer | No US match | — |
| Mar 30, 2017 | MundesineForodesine hydrochloride | Mundipharma K.K. | Cancer | No US match | — |
| Mar 30, 2017 | NinlaroIxazomib citrate | Takeda Pharmaceutical Company Limited | Cancer | Nov 20, 2015 | 16 mo later |
| Mar 30, 2017 | KcentraFreeze-dried human prothrombin complex concentrated | CSL Behring K.K. | Blood products | No US match | — |
| Dec 19, 2016 | ParsabivEtelcalcetide hydrochloride | Ono Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Feb 7, 2017 | 2 mo earlier |
| Dec 19, 2016 | LinzessLinaclotide | Astellas Pharma Inc. | Gastrointestinal, skin and immune | Aug 30, 2012 | 52 mo later |
| Dec 19, 2016 | TecfideraDimethyl fumarate | Biogen Japan Ltd. | Nervous system | Mar 27, 2013 | 45 mo later |
| Dec 19, 2016 | XimencyDaclatasvir hydrochloride/ Asunaprevir/ Beclabuvir hydrochloride | Bristol-Myers Squibb K.K. | Infections | No US match | — |
| Dec 19, 2016 | RiametArtemether/ Lumefantrine | Novartis Pharma K.K. | Infections | No US match | — |
| Dec 19, 2016 | VemlidyTenofovir alafenamide fumarate | Gilead Sciences, Inc. | Infections | Nov 10, 2016 | 1 mo later |
| Dec 19, 2016 | OtezlaApremilast | Celgene K.K. | Respiratory and allergy | Mar 21, 2014 | 33 mo later |
| Dec 19, 2016 | Amyvid18 F) | Fujifilm RI Pharma Co., Ltd. | Radiopharmaceuticals | No US match | — |
| Dec 19, 2016 | ErwinaseCrisantaspase | Ohara Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Dec 19, 2016 | MozobilPlerixafor | Sanofi K.K. | Cancer | Dec 15, 2008 | 96 mo later |
| Nov 22, 2016 | PrezcobixDarunavir ethanolate/ Cobicistat | Janssen Pharmaceutical K.K. | HIV | No US match | — |
| Sep 28, 2016 | BrilintaTicagrelor | AstraZeneca K.K. | Heart, Parkinson's and Alzheimer's | Jul 20, 2011 | 62 mo later |
| Sep 28, 2016 | UptraviSelexipag | Nippon Shinyaku Co., Ltd. | Heart, Parkinson's and Alzheimer's | Dec 21, 2015 | 9 mo later |
| Sep 28, 2016 | JuxtapidLomitapide mesilate | Aegerion Pharmaceuticals K.K. | Heart, Parkinson's and Alzheimer's | Dec 21, 2012 | 45 mo later |
| Sep 28, 2016 | PrizbindIdarucizumab (genetical recombination) | Nippon Boehringer Ingelheim Co., Ltd. | Heart, Parkinson's and Alzheimer's | Oct 16, 2015 | 11 mo later |
| Sep 28, 2016 | RifximaRifaximin | Aska Pharmaceutical Co., Ltd. | Infections | May 25, 2004 | 148 mo later |
| Sep 28, 2016 | GrazynaGrazoprevir hydrate | MSD K.K. | Infections | No US match | — |
| Sep 28, 2016 | ErelsaElbasvir | MSD K.K. | Infections | No US match | — |
| Sep 28, 2016 | OvidrelChoriogonadotropin alfa (genetical recombination) | Merck Serono Co., Ltd. | Reproductive and urinary | Sep 20, 2000 | 192 mo later |
| Sep 28, 2016 | DesalexDesloratadine | MSD K.K. | Respiratory and allergy | Dec 21, 2001 | 177 mo later |
| Sep 28, 2016 | BilanoaBilastine | Taiho Pharmaceutical Co. Ltd. | Respiratory and allergy | No US match | — |
| Sep 28, 2016 | Signifor LARPasireotide pamoate | Novartis Pharma K.K. | Hormones and metabolism | Dec 15, 2014 | 21 mo later |
| Sep 28, 2016 | Carbaglu DispersibleCarglumic acid | Pola Pharma Inc. | Hormones and metabolism | Mar 18, 2010 | 78 mo later |
| Sep 28, 2016 | KeytrudaPembrolizumab (genetical recombination) | MSD K.K. | Cancer | Sep 4, 2014 | 25 mo later |
| Sep 28, 2016 | EmplicitiElotuzumab (genetical recombination) | Bristol-Myers Squibb Company | Cancer | Nov 30, 2015 | 10 mo later |
| Sep 28, 2016 | IclusigPonatinib hydrochloride | Otsuka Pharmaceutical Co., Ltd. | Cancer | Dec 14, 2012 | 45 mo later |
| Sep 28, 2016 | IdelvionAlbutrepenonacog alfa (genetical recombination) | CSL Behring K.K. | Blood products | No US match | — |
| Jul 4, 2016 | PraluentAlirocumab (genetical recombination) | Sanofi K.K. | Heart, Parkinson's and Alzheimer's | Jul 24, 2015 | 11 mo later |
| Jul 4, 2016 | OcnobelOxcarbazepine | Nobelpharma Co., Ltd. | Nervous system | Jan 14, 2000 | 198 mo later |
| Jul 4, 2016 | VimpatLacosamide | UCB Japan Co., Ltd. | Nervous system | Oct 28, 2008 | 92 mo later |
| Jul 4, 2016 | TaltzIxekizumab (genetical recombination) | Eli Lilly Japan K.K. | Respiratory and allergy | Mar 22, 2016 | 3 mo later |
| Jul 4, 2016 | LumicefBrodalumab (genetical recombination) | Kyowa Hakko Kirin Co., Ltd. | Respiratory and allergy | Feb 15, 2017 | 7 mo earlier |
| Jul 4, 2016 | KyprolisCarfilzomib | Ono Pharmaceutical Co., Ltd. | Cancer | Jul 20, 2012 | 47 mo later |
| Jun 17, 2016 | GenvoyaElvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir alafenamide fumarate | Japan Tobacco Inc. | HIV | No US match | — |
| Mar 28, 2016 | Sabril Granule SachetsVigabatrin | Sanofi K.K. | Nervous system | Aug 21, 2009 | 79 mo later |
| Mar 28, 2016 | Sycrest SublingualAsenapine maleate | Meiji Seika Pharma Co., Ltd. | Nervous system | Aug 13, 2009 | 79 mo later |
| Mar 28, 2016 | FycompaPerampanel hydrate | Eisai Co., Ltd. | Nervous system | Oct 22, 2012 | 41 mo later |
| Mar 28, 2016 | PrimaquinePrimaquine phosphate | Sanofi K.K. | Infections | No US match | — |
| Mar 28, 2016 | NucalaMepolizumab (genetical recombination) | GlaxoSmithKline K.K. | Respiratory and allergy | Nov 4, 2015 | 5 mo later |
| Mar 28, 2016 | KanumaSebelipase alfa (genetical recombination) | Alexion Pharma G.K. | Hormones and metabolism | Dec 8, 2015 | 4 mo later |
| Mar 28, 2016 | TafinlarDabrafenib mesilate | Novartis Pharma K.K. | Cancer | May 29, 2013 | 34 mo later |
| Mar 28, 2016 | MekinistTrametinib dimethyl sulfoxide | Novartis Pharma K.K. | Cancer | May 29, 2013 | 34 mo later |
| Mar 28, 2016 | Xofigo（ 223 Ra） | Bayer Yakuhin, Ltd. | Cancer | No US match | — |
| Mar 28, 2016 | ZykadiaCeritinib | Novartis Pharma K.K. | Cancer | Apr 29, 2014 | 23 mo later |
| Mar 28, 2016 | TagrissoOsimertinib mesilate | AstraZeneca K.K. | Cancer | Nov 13, 2015 | 4 mo later |
| Mar 28, 2016 | ImbruvicaIbrutinib | Janssen Pharmaceutical K.K. | Cancer | Feb 12, 2014 | 25 mo later |
| Mar 28, 2016 | AdynovateRurioctocog alfa pegol (genetical recombination) | Baxter Limited | Blood products | No US match | — |
| Mar 28, 2016 | KovaltryOctocog beta (genetical recombination) | Bayer Yakuhin, Ltd. | Blood products | No US match | — |
| Jan 22, 2016 | Repatha･SCEvolocumab (genetical recombination) | Amgen Astellas BioPharma K.K. | Heart, Parkinson's and Alzheimer's | Feb 26, 2021 | 61 mo earlier |
| Jan 22, 2016 | ProvocholineMethacholine chloride | Santen Pharmaceutical Co., Ltd. | Diagnostic agents | No US match | — |
| Jan 22, 2016 | TargretinBexarotene | Minophagen Pharmaceutical Co., Ltd. | Cancer | Dec 29, 1999 | 193 mo later |
| Jan 22, 2016 | Vaxem HibHaemophilus influenzae type b vaccine absorbed (mutated diphtheria CRM conjugate) 197 | Takeda Pharmaceutical Company Limited | Vaccines | No US match | — |
| Sep 28, 2015 | P-Tol ChewableSucroferric oxyhydroxide | Kissei Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Sep 28, 2015 | MulpletaLusutrombopag | Shionogi & Co., Ltd. | Heart, Parkinson's and Alzheimer's | Jul 31, 2018 | 34 mo earlier |
| Sep 28, 2015 | Ventavis inhalation solutionIloprost | Bayer Yakuhin, Ltd. | Heart, Parkinson's and Alzheimer's | Dec 29, 2004 | 129 mo later |
| Sep 28, 2015 | Effexor SRVenlafaxine hydrochloride | Pfizer Japan Inc. | Nervous system | May 20, 2008 | 88 mo later |
| Sep 28, 2015 | Copaxone S.C.Glatiramer acetate | Takeda Pharmaceutical Company Limited | Nervous system | No US match | — |
| Sep 28, 2015 | ZebiaxOzenoxacin | Maruho Co., Ltd. | Infections | Dec 11, 2017 | 26 mo earlier |
| Sep 28, 2015 | ViekiraxOmbitasvir hydrate/Paritaprevir hydrate/Ritonavir | AbbVie G.K. | Infections | No US match | — |
| Sep 28, 2015 | Spiolto RespimatTiotropium bromide hydrate/Olodaterol hydrochloride | Nippon Boehringer Ingelheim Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 28, 2015 | LoqoaEsflurbiprofen/Mentha oil | Taisho Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 28, 2015 | Miticure House Dust Mite SublingualDermatophagoides farinae extract, Dermatophagoides pteronyssinus extract | Torii Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Sep 28, 2015 | MarizevOmarigliptin | MSD K.K. | Hormones and metabolism | No US match | — |
| Sep 28, 2015 | OctreoscanIndium pentetoreotide 111 ( In) | Fujifilm RI Pharma Co.,Ltd. | Radiopharmaceuticals | No US match | — |
| Sep 28, 2015 | CaprelsaVandetanib | AstraZeneca K.K. | Cancer | Apr 6, 2011 | 54 mo later |
| Sep 28, 2015 | YondelisTrabectedin | Taiho Pharmaceutical Co., Ltd. | Cancer | Oct 23, 2015 | 1 mo earlier |
| Jul 3, 2015 | Xiaflex lnj.Collagenase (Clostridium histolyticum ) | Asahi Kasei Pharma Corporation | Gastrointestinal, skin and immune | No US match | — |
| Jul 3, 2015 | HarvoniLedipasvir acetonate/Sofosbuvir | Gilead Sciences, Inc. | Infections | No US match | — |
| Jul 3, 2015 | Olanedine AntisepticOlanexidine gluconate | Otsuka Pharmaceutical Factory, Inc. | Infections | No US match | — |
| Jul 3, 2015 | PlaquenilHydroxychloroquine sulfate | Sanofi K.K. | Respiratory and allergy | Jan 14, 2022 | 78 mo earlier |
| Jul 3, 2015 | OfevNintedanib ethanesulfonate | Nippon Boehringer Ingelheim Co., Ltd. | Respiratory and allergy | No US match | — |
| Jul 3, 2015 | TrulicityDulaglutide (genetical recombination) | Eli Lilly Japan K.K. | Hormones and metabolism | Sep 18, 2014 | 9 mo later |
| Jul 3, 2015 | StrensiqAsfotase alfa (genetical recombination) | Alexion Pharma G.K. | Hormones and metabolism | Oct 23, 2015 | 4 mo earlier |
| Jul 3, 2015 | YervoyIpilimumab (genetical recombination) | Bristol-Myers K.K. | Cancer | Mar 25, 2011 | 51 mo later |
| Jul 3, 2015 | FarydakPanobinostat lactate | Novartis Pharma K.K. | Cancer | Feb 23, 2015 | 4 mo later |
| Jul 3, 2015 | AcoalanAntithrombin gamma (genetical recombination) | Kyowa Hakko Kirin Co., Ltd. | Blood products | No US match | — |
| Mar 26, 2015 | OpsumitMacitentan | Actelion Pharmaceuticals Japan Ltd. | Heart, Parkinson's and Alzheimer's | Oct 18, 2013 | 17 mo later |
| Mar 26, 2015 | DuacClindamycin phosphate hydrate/ Benzoyl peroxide | GlaxoSmithKline K.K. | Infections | No US match | — |
| Mar 26, 2015 | SovaldiSofosbuvir | Gilead Sciences, Inc. | Infections | Dec 6, 2013 | 16 mo later |
| Mar 26, 2015 | EkliraAclidinium bromide | Kyorin Pharmaceutical Co., Ltd. | Respiratory and allergy | Jul 23, 2012 | 32 mo later |
| Mar 26, 2015 | ActairDermatophagoides farinae extract bulk powder, Dermatophagoides pteronyssinus extract bulk powder | Shionogi & Co., Ltd. | Respiratory and allergy | No US match | — |
| Mar 26, 2015 | ZafatekTrelagliptin succinate | Takeda Pharmaceutical Company Limited | Hormones and metabolism | No US match | — |
| Mar 26, 2015 | CerdelgaEliglustat tartrate | Genzyme Japan K.K | Hormones and metabolism | Aug 19, 2014 | 7 mo later |
| Mar 26, 2015 | Gadovist IVGadobutrol | Bayer Yakuhin, Ltd. | Diagnostic agents | Mar 14, 2011 | 48 mo later |
| Mar 26, 2015 | LenvimaLenvatinib mesilate | Eisai Co., Ltd. | Cancer | Feb 13, 2015 | 1 mo later |
| Mar 26, 2015 | PomalystPomalidomide | Celgene K.K. | Cancer | Feb 8, 2013 | 25 mo later |
| Mar 26, 2015 | CyramzaRamucirumab (genetical recombination) | Eli Lilly Japan K.K. | Cancer | Apr 21, 2014 | 11 mo later |
| Mar 26, 2015 | Cell Culture-derived InfluenzaCell culture-derived influenza emulsion HA vaccines (prototype) | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Vaccines | No US match | — |
| Mar 26, 2015 | Synflorix AqueousPneumococcal 10- valent conjugate vaccine adsorbed (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) | Japan Vaccine Co., Ltd. | Vaccines | No US match | — |
| Mar 26, 2015 | NovoThirteen i.v.injectionCatridecacog (genetical recombination) | Novo Nordisk Pharma Ltd. | Blood products | No US match | — |
| Dec 26, 2014 | TakecabVonoprazan fumarate | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | Nov 1, 2023 | 106 mo earlier |
| Dec 26, 2014 | Methylene BlueMethylthioninium chloride hydrate | Daiichi Sankyo Company, Limited | Gastrointestinal, skin and immune | No US match | — |
| Dec 26, 2014 | BepioBenzoyl peroxide | Maruho Co., Ltd. | Gastrointestinal, skin and immune | Apr 22, 2022 | 88 mo earlier |
| Dec 26, 2014 | NopicorNalfurafine hydrochloride | Toray Medical Co., Ltd. | Anesthesia, eye and narcotics | No US match | — |
| Dec 26, 2014 | Allergen ExtractDermatophagoides farinae extract 10,000 AU/mL, Dermatophagoides pteronyssinus extract 10,000 AU/mL | Torii Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Dec 26, 2014 | CosentyxSecukinumab (genetical recombination) | Novartis Pharma K.K. | Respiratory and allergy | Jan 21, 2015 | 1 mo earlier |
| Dec 26, 2014 | Allergen ExtractDermatophagoides farinae extract 10,000 AU/mL, Dermatophagoides pteronyssinus extract 10,000 AU/mL | Torii Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Dec 26, 2014 | OrfadinNitisinone | Astellas Pharma Inc. | Hormones and metabolism | Jan 18, 2002 | 155 mo later |
| Dec 26, 2014 | JardianceEmpagliflozin | Nippon Boehringer Ingelheim Co., Ltd. | Hormones and metabolism | Aug 1, 2014 | 5 mo later |
| Dec 26, 2014 | VimizimElosulfase alfa (genetical recombination) | BioMarin Pharmaceutical Japan K.K. | Hormones and metabolism | Feb 14, 2014 | 10 mo later |
| Dec 26, 2014 | ZelborafVemurafenib | Chugai Pharmaceutical Co., Ltd. | Cancer | Aug 17, 2011 | 40 mo later |
| Dec 26, 2014 | RixubisNonacog gamma (genetical recombination) | Baxter Limited | Blood products | No US match | — |
| Dec 26, 2014 | EloctateEfraloctocog alfa (genetical recombination) | Biogen Idec Japan Ltd. | Blood products | No US match | — |
| Sep 26, 2014 | FomepizoleFomepizole | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | No US match | — |
| Sep 26, 2014 | BelsomraSuvorexant | MSD K.K. | Nervous system | Aug 13, 2014 | 1 mo later |
| Sep 26, 2014 | GlanatecRipasudil hydrochloride hydrate | Kowa Company, Ltd. | Anesthesia, eye and narcotics | No US match | — |
| Sep 26, 2014 | VanihepVaniprevir | MSD K.K. | Infections | No US match | — |
| Sep 26, 2014 | G-LastaPegfilgrastim (genetical recombination) | Kyowa Hakko Kirin Co., Ltd. | Cancer | Jan 31, 2002 | 152 mo later |
| Sep 26, 2014 | AgrylinAnagrelide hydrochloride hydrate | Shire Japan KK | Cancer | No US match | — |
| Sep 26, 2014 | MabCampathAlemtuzumab (genetical recombination) | Sanofi K.K. | Cancer | May 7, 2001 | 161 mo later |
| Sep 26, 2014 | BosulifBosutinib hydrate | Pfizer Japan Inc. | Cancer | Sep 4, 2012 | 25 mo later |
| Sep 26, 2014 | ZanosarStreptozocin | Nobelpharma Co., Ltd. | Cancer | No US match | — |
| Jul 4, 2014 | Clenafin TopicalEfinaconazole | Kaken Pharmaceutical Co., Ltd. | Infections | Jun 6, 2014 | 1 mo later |
| Jul 4, 2014 | DeltybaDelamanid | Otsuka Pharmaceutical Co., Ltd. | Infections | No US match | — |
| Jul 4, 2014 | DaklinzaDaclatasvir hydrochloride Asunaprevir | Bristol-Myers K.K. | Infections | No US match | — |
| Jul 4, 2014 | Anoro Ellipta(1) Umeclidinium bromide/ (2) Vilanterol trifenatate | GlaxoSmithKline K.K. | Respiratory and allergy | No US match | — |
| Jul 4, 2014 | RapalimusSirolimus | Nobelpharma Co., Ltd. | Respiratory and allergy | Sep 15, 1999 | 178 mo later |
| Jul 4, 2014 | CanagluCanagliflozin hydrate | Mitsubishi Tanabe Pharma Corporation | Hormones and metabolism | Mar 29, 2013 | 15 mo later |
| Jul 4, 2014 | VprivVelaglucerase alfa (genetical recombination) | Shire Japan KK | Hormones and metabolism | Feb 26, 2010 | 52 mo later |
| Jul 4, 2014 | NicystagonCysteamine bitartrate | Mylan Seiyaku Ltd. | Hormones and metabolism | Apr 30, 2013 | 14 mo later |
| Jul 4, 2014 | ZytigaAbiraterone acetate | Janssen Pharmaceutical K.K. | Cancer | Apr 28, 2011 | 38 mo later |
| Jul 4, 2014 | JevtanaCabazitaxel acetonate | Sanofi K.K. | Cancer | No US match | — |
| Jul 4, 2014 | JakaviRuxolitinib phosphate | Novartis Pharma K.K. | Cancer | Nov 16, 2011 | 32 mo later |
| Jul 4, 2014 | AlecensaAlectinib hydrochloride | Chugai Pharmaceutical Co., Ltd. | Cancer | Dec 11, 2015 | 17 mo earlier |
| Jul 4, 2014 | OpdivoNivolumab (genetical recombination) | Ono Pharmaceutical Co., Ltd. | Cancer | Dec 22, 2014 | 6 mo earlier |
| Jul 4, 2014 | MenactraMeningococcal quadrivalent vaccine (diphtheria toxoid conjugate) | Sanofi K.K. | Vaccines | No US match | — |
| Jul 4, 2014 | ByclotFreeze-dried activated human blood coagulation factor VII concentrate containing factor X | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Blood products | No US match | — |
| Jul 4, 2014 | AlprolixEftrenonacog alfa (genetical recombination) | Biogen Idec Japan Ltd. | Blood products | No US match | — |
| Mar 24, 2014 | TreprostTreprostinil | Mochida Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | May 21, 2002 | 142 mo later |
| Mar 24, 2014 | EfientPrasugrel hydrochloride | Daiichi Sankyo Company, Limited | Heart, Parkinson's and Alzheimer's | Jul 10, 2009 | 56 mo later |
| Mar 24, 2014 | TysabriNatalizumab (genetical recombination) | Biogen Idec Japan Ltd. | Nervous system | Nov 23, 2004 | 112 mo later |
| Mar 24, 2014 | TapentaTapentadol hydrochloride | Janssen Pharmaceutical K.K. | Anesthesia, eye and narcotics | Nov 20, 2008 | 64 mo later |
| Mar 24, 2014 | AviganFavipiravir | Toyama Chemical Co., Ltd. | Infections | No US match | — |
| Mar 24, 2014 | TenozetTenofovir disoproxil fumarate | GlaxoSmithKline K.K. | Infections | Oct 26, 2001 | 149 mo later |
| Mar 24, 2014 | ForxigaDapagliflozin propylene glycolate hydrate | Bristol-Myers K.K. | Hormones and metabolism | No US match | — |
| Mar 24, 2014 | LusefiLuseogliflozin hydrate | Taisho Pharmaceutical Co., Ltd. | Hormones and metabolism | No US match | — |
| Mar 24, 2014 | DeberzaTofogliflozin hydrate | Sanofi K.K. | Hormones and metabolism | No US match | — |
| Mar 24, 2014 | LonsurfTrifluridine/tipiracil hydrochloride | Taiho Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Mar 24, 2014 | XtandiEnzalutamide | Astellas Pharma Inc. | Cancer | Aug 31, 2012 | 19 mo later |
| Mar 24, 2014 | TivicayDolutegravir sodium | ViiV Healthcare K.K. | HIV | Aug 12, 2013 | 7 mo later |
| Mar 24, 2014 | Cell Culture-derived InfluenzaCell culture-derived influenza emulsion HA vaccine (H5N1) | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Vaccines | No US match | — |
| Mar 24, 2014 | Adsorbed Cell Culture-derived Influenza Vaccine H5N1Adsorbed cell culture- derived influenza vaccine (H5N1) | Kitasato Daiichi Sankyo Vaccine Co., Ltd. | Vaccines | No US match | — |
| Jan 17, 2014 | RionaFerric citrate hydrate | Japan Tobacco Inc. | Gastrointestinal, skin and immune | Sep 5, 2014 | 8 mo earlier |
| Jan 17, 2014 | Savene InjectableDexrazoxane | Kissei Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Sep 6, 2007 | 76 mo later |
| Jan 17, 2014 | AdempasRiociguat | Bayer Yakuhin, Ltd. | Heart, Parkinson's and Alzheimer's | Oct 8, 2013 | 3 mo later |
| Jan 17, 2014 | SuglatIpragliflozin L-proline | Astellas Pharma Inc. | Hormones and metabolism | No US match | — |
| Jan 17, 2014 | CystadaneBetaine | ReqMed Company, Ltd. | Hormones and metabolism | No US match | — |
| Jan 17, 2014 | GiotrifAfatinib maleate | Nippon Boehringer Ingelheim Co., Ltd. | Cancer | No US match | — |
| Jan 17, 2014 | AdcetrisBrentuximab vedotin (genetical recombination) | Takeda Pharmaceutical Company Limited | Cancer | Aug 19, 2011 | 29 mo later |
| Jan 17, 2014 | NovoEight i.v.injectionTuroctocog alpha (genetical recombination) | Not listed | Blood products | No US match | — |
| Sep 27, 2013 | SovriadSimeprevir sodium | Janssen Pharmaceutical K.K. | Infections | Nov 22, 2013 | 2 mo earlier |
| Sep 27, 2013 | HizentrapH4-treated normal human immunoglobulin (subcutaneous injection) | CSL Behring K.K. | Blood products | No US match | — |
| Sep 20, 2013 | ObleanCetilistat | Takeda Pharmaceutical Company Limited | Gastrointestinal, skin and immune | No US match | — |
| Sep 20, 2013 | Xeplion AqueousPaliperidone palmitate | Janssen Pharmaceutical K.K. | Nervous system | Jul 31, 2009 | 50 mo later |
| Sep 20, 2013 | VyndaqelTafamidis meglumine | Pfizer Japan Inc. | Nervous system | May 3, 2019 | 67 mo earlier |
| Sep 20, 2013 | Relvar(1) Vilanterol trifenatate (2) Fluticasone furoate | GlaxoSmithKline K.K. | Respiratory and allergy | No US match | — |
| Sep 20, 2013 | DaTscanIoflupane (123I) | Nihon Medi-Physics Co., Ltd. | Radiopharmaceuticals | No US match | — |
| Sep 20, 2013 | Unitalc IntrapleuralSterile talc | Nobelpharma Co., Ltd. | Cancer | No US match | — |
| Sep 20, 2013 | KadcylaTrastuzumab emtansine (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | No US match | — |
| Jun 28, 2013 | BisonoBisoprolol | Toa Eiyo Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jun 28, 2013 | TopiloricTopiroxostat | Sanwa Kagaku Kenkyusho Co., Ltd. | Hormones and metabolism | No US match | — |
| Jun 28, 2013 | LyxumiaLixisenatide | Sanofi K.K. | Hormones and metabolism | Jul 27, 2016 | 37 mo earlier |
| Jun 28, 2013 | Bonviva IVIbandronate sodium hydrate | Chugai Pharmaceutical Co., Ltd. | Hormones and metabolism | May 16, 2003 | 121 mo later |
| Jun 28, 2013 | PerjetaPertuzumab (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Cancer | Jun 8, 2012 | 13 mo later |
| Jun 18, 2013 | PrevenarPneumococcal 13- valent conjugate vaccine adsorbed (mutated diphtheria CRM conjugate) 197 | Pfizer Japan Inc. | Vaccines | No US match | — |
| Jun 18, 2013 | Cell Culture-derived Influenza Vaccine H5N1Cell culture-derived influenza vaccine (H5N1) | Takeda Pharmaceutical Company Limited | Vaccines | No US match | — |
| Apr 26, 2013 | Cell Culture-derived Influenza VaccineCell culture-derived influenza vaccines (prototype) | Takeda Pharmaceutical Company Limited | Vaccines | No US match | — |
| Mar 25, 2013 | AcofideAcotiamide hydrochloride hydrate | Zeria Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Mar 25, 2013 | NouriastIstradefylline | Kyowa Hakko Kirin Co., Ltd. | Heart, Parkinson's and Alzheimer's | Aug 27, 2019 | 77 mo earlier |
| Mar 25, 2013 | RegtectAcamprosate calcium | Nippon Shinyaku Co., Ltd. | Nervous system | Jul 29, 2004 | 104 mo later |
| Mar 25, 2013 | InovelonRufinamide | Eisai Co., Ltd. | Nervous system | Nov 14, 2008 | 52 mo later |
| Mar 25, 2013 | VoluvenHydroxyethylated starch 130000 | Fresenius Kabi Japan K.K. | Reproductive and urinary | No US match | — |
| Mar 25, 2013 | XeljanzTofacitinib citrate | Pfizer Japan Inc. | Respiratory and allergy | Nov 6, 2012 | 5 mo later |
| Mar 25, 2013 | OnglyzaSaxagliptin hydrate | Otsuka Pharmaceutical Co., Ltd. | Hormones and metabolism | Jul 31, 2009 | 44 mo later |
| Mar 25, 2013 | MetreleptinMetreleptin (genetical recombination) | Shionogi & Co., Ltd. | Hormones and metabolism | Feb 24, 2014 | 11 mo earlier |
| Mar 25, 2013 | AlabelAminolevulinic acid hydrochloride | SBI Pharmaceuticals Co., Ltd. | Diagnostic agents | Dec 3, 1999 | 160 mo later |
| Mar 25, 2013 | ArzerraOfatumumab (genetical recombination) | GlaxoSmithKline K.K. | Cancer | Oct 26, 2009 | 41 mo later |
| Mar 25, 2013 | EvoltraClofarabine | Genzyme Japan K.K. | Cancer | Dec 28, 2004 | 99 mo later |
| Mar 25, 2013 | Stivarga tabletsRegorafenib hydrate | Bayer Yakuhin, Ltd. | Cancer | Sep 27, 2012 | 6 mo later |
| Mar 25, 2013 | StribildElvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate | Japan Tobacco Inc. | HIV | No US match | — |
| Mar 25, 2013 | Adsorbed Influenza VaccineAdsorbed influenza vaccine (H5N1) | Denka Seiken Co., Ltd. | Vaccines | No US match | — |
| Mar 25, 2013 | NormosangHemin | CMIC Holdings Co., Ltd. | Blood products | No US match | — |
| Dec 25, 2012 | EliquisApixaban | Bristol-Myers K.K. | Heart, Parkinson's and Alzheimer's | Dec 28, 2012 | Same month |
| Dec 25, 2012 | [1] NeuproRotigotine | Otsuka Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | May 9, 2007 | 68 mo later |
| Dec 25, 2012 | ChoreazineTetrabenazine | Alfresa Pharma Corporation | Nervous system | Aug 15, 2008 | 52 mo later |
| Dec 25, 2012 | MalaroneAtovaquone/proguanil hydrochloride | GlaxoSmithKline K.K. | Infections | No US match | — |
| Dec 25, 2012 | AmeparomoParomomycin sulfate | Pfizer Japan Inc. | Infections | No US match | — |
| Dec 25, 2012 | ToviazFesoterodine fumarate | Pfizer Japan Inc. | Reproductive and urinary | Oct 31, 2008 | 50 mo later |
| Dec 25, 2012 | CimziaCertolizumab pegol (genetical recombination) | UCB Japan Co., Ltd. | Respiratory and allergy | Apr 22, 2008 | 56 mo later |
| Dec 25, 2012 | L-Cartin FFLevocarnitine | Otsuka Pharmaceutical Co., Ltd. | Hormones and metabolism | No US match | — |
| Sep 28, 2012 | Lotriga Granularomega-3-acid ethyl esters | Takeda Pharmaceutical Company Limited | Heart, Parkinson's and Alzheimer's | Nov 10, 2004 | 95 mo later |
| Sep 28, 2012 | Diacomit DrysyrupStiripentol | Meiji Seika Pharma Co., Ltd. | Nervous system | Aug 20, 2018 | 71 mo earlier |
| Sep 28, 2012 | EyleaAflibercept (genetical recombination) | Bayer Yakuhin, Ltd. | Anesthesia, eye and narcotics | Nov 18, 2011 | 10 mo later |
| Sep 28, 2012 | MethapainMethadone hydrochloride | Teikoku Seiyaku Co., Ltd. | Anesthesia, eye and narcotics | No US match | — |
| Sep 28, 2012 | TygacilTigecycline | Pfizer Japan Inc. | Infections | Jun 15, 2005 | 87 mo later |
| Sep 28, 2012 | SeebriGlycopyrronium bromide | Novartis Pharma K.K. | Respiratory and allergy | Jun 28, 2018 | 69 mo earlier |
| Sep 28, 2012 | SuinyAnagliptin | Kowa Pharmaceutical Co. Ltd. | Hormones and metabolism | No US match | — |
| Sep 28, 2012 | Tresiba Flex Touch Tresiba PenfillInsulin degludec (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Sep 25, 2015 | 36 mo earlier |
| Sep 28, 2012 | BuphenylSodium phenylbutyrate | CMIC Holdings, Co., Ltd. | Hormones and metabolism | Jun 17, 2022 | 117 mo earlier |
| Sep 28, 2012 | GliadelCarmustine | Nobelpharma Co., Ltd. | Cancer | May 16, 2022 | 116 mo earlier |
| Sep 28, 2012 | VotrientPazopanib hydrochloride | GlaxoSmithKline K.K. | Cancer | Oct 19, 2009 | 35 mo later |
| Jul 27, 2012 | TetrabikAdsorbed diphtheria- purified pertussis-tetanus- inactivated polio (Sabin strain) combined vaccine | The Research Foundation for Microbial Diseases of Osaka University | Biologics | No US match | — |
| Jul 27, 2012 | QuattrovacAdsorbed diphtheria- purified pertussis-tetanus- inactivated polio (Sabin strain) combined vaccine | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Biologics | No US match | — |
| Jun 29, 2012 | AmitizaLubiprostone | Sucampo Pharma. Ltd. | Gastrointestinal, skin and immune | Jan 31, 2006 | 77 mo later |
| Jun 29, 2012 | KolbetIguratimod | Eisai Co., Ltd. | Respiratory and allergy | No US match | — |
| Jun 29, 2012 | TeneliaTeneligliptin hydrobromide hydrate | Mitsubishi Tanabe Pharma Corporation | Hormones and metabolism | No US match | — |
| Jun 29, 2012 | SomatulineLanreotide acetate | Teijin Pharma Limited | Hormones and metabolism | Aug 30, 2007 | 58 mo later |
| Jun 29, 2012 | GonaxDegarelix acetate | Astellas Pharma Inc. | Cancer | Dec 24, 2008 | 42 mo later |
| Jun 29, 2012 | InlytaAxitinib | Pfizer Japan Inc. | Cancer | Jan 27, 2012 | 5 mo later |
| May 18, 2012 | EdurantRilpivirine hydrochloride | Janssen Pharmaceutical K.K. | HIV | May 20, 2011 | 12 mo later |
| Apr 27, 2012 | Imovax PolioInactivated poliomyelitis vaccine (Salk vaccine) | Sanofi Pasteur | Biologics | No US match | — |
| Mar 30, 2012 | KiklinBixalomer | Astellas Pharma Inc. | Gastrointestinal, skin and immune | No US match | — |
| Mar 30, 2012 | ApokynApomorphine hydrochloride hydrate | Kyowa Hakko Kirin Co., Ltd. | Heart, Parkinson's and Alzheimer's | Apr 20, 2004 | 95 mo later |
| Mar 30, 2012 | PulmozymeDornase alfa (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Mar 30, 2012 | BrazavesMiglustat | Actelion Pharmaceuticals Japan Ltd. | Hormones and metabolism | Jul 31, 2003 | 104 mo later |
| Mar 30, 2012 | PoteligeoMogamulizumab (genetical recombination) | Kyowa Hakko Kirin Co., Ltd. | Cancer | Aug 8, 2018 | 76 mo earlier |
| Mar 30, 2012 | XalkoriCrizotinib | Pfizer Japan Inc. | Cancer | Aug 26, 2011 | 7 mo later |
| Jan 18, 2012 | AzilvaAzilsartan | Takeda Pharmaceutical Company Limited | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 18, 2012 | XareltoRivaroxaban | Bayer Yakuhin, Ltd. | Heart, Parkinson's and Alzheimer's | Jul 1, 2011 | 7 mo later |
| Jan 18, 2012 | LunestaEszopiclone | Eisai Co., Ltd. | Nervous system | Dec 15, 2004 | 85 mo later |
| Jan 18, 2012 | RegniteGabapentin enacarbil | Astellas Pharma Inc. | Nervous system | Apr 6, 2011 | 9 mo later |
| Jan 18, 2012 | AiphaganBrimonidine tartrate | Senju Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | Mar 16, 2001 | 130 mo later |
| Jan 18, 2012 | EmlaLidocaine/propitocaine | Sato Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | No US match | — |
| Jan 18, 2012 | SamtirelAtovaquone | GlaxoSmithKline K.K. | Infections | No US match | — |
| Jan 18, 2012 | CancidasCaspofungin acetate | MSD K.K. | Infections | Jan 26, 2001 | 132 mo later |
| Jan 18, 2012 | RanmarkDenosumab (genetical recombination) | Daiichi Sankyo Company, Limited | Cancer | Jun 1, 2010 | 20 mo later |
| Jan 18, 2012 | RotaTeqLive attenuated rotavirus vaccine, oral, pentavalent | MSD K.K. | Biologics | No US match | — |
| Sep 26, 2011 | ProemendFosaprepitant meglumine | Ono Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Sep 26, 2011 | ImuseraFingolimod hydrochloride | Novartis Pharma K.K. | Nervous system | Sep 21, 2010 | 12 mo later |
| Sep 26, 2011 | TelavicTelaprevir | Mitsubishi Tanabe Pharma Corporation | Infections | May 23, 2011 | 4 mo later |
| Sep 26, 2011 | IlarisCanakinumab (genetical recombination) | Novartis Pharma K.K. | Respiratory and allergy | Jun 17, 2009 | 27 mo later |
| Sep 26, 2011 | FaslodexFulvestrant | AstraZeneca K.K. | Cancer | Apr 25, 2002 | 113 mo later |
| Sep 16, 2011 | Levemir Penfill Levemir FlexPen Levemir InnoLetInsulin detemir (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Oct 19, 2005 | 71 mo later |
| Jul 1, 2011 | NexiumEsomeprazole magnesium hydrate Esomeprazole magnesium hydrate | AstraZeneca K.K. | Gastrointestinal, skin and immune | No US match | — |
| Jul 1, 2011 | Ditripentat-CalPentetate calcium trisodium Pentetate zinc trisodium | Nihon Medi-Physics Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Jul 1, 2011 | FostoinFosphenytoin sodium hydrate | Nobelpharma Co., Ltd. | Nervous system | Nov 5, 2020 | 112 mo earlier |
| Jul 1, 2011 | Cubicin IVDaptomycin | MSD K.K. | Infections | Sep 12, 2003 | 94 mo later |
| Jul 1, 2011 | BetanisMirabegron | Astellas Pharma Inc. | Reproductive and urinary | Jun 28, 2012 | 12 mo earlier |
| Jul 1, 2011 | SimponiGolimumab (genetical recombination) | Janssen Pharmaceutical K.K. | Respiratory and allergy | Apr 24, 2009 | 26 mo later |
| Jul 1, 2011 | OnbrezIndacaterol maleate | Novartis Pharma K.K. | Respiratory and allergy | Jul 1, 2011 | Same month |
| Jul 1, 2011 | TrazentaLinagliptin | Nippon Boehringer Ingelheim Co., Ltd. | Hormones and metabolism | May 2, 2011 | 2 mo later |
| Jul 1, 2011 | ZolinzaVorinostat | MSD K.K. | Cancer | Oct 6, 2006 | 57 mo later |
| Jul 1, 2011 | RotarixLive attenuated human rotavirus vaccine, oral | GlaxoSmithKline K.K. | Biologics | No US match | — |
| Jul 1, 2011 | Gardasil AqueousRecombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine (yeast origin) | MSD K.K. | Biologics | No US match | — |
| Apr 22, 2011 | LipacreonPancrelipase | Abbott Japan Co., Ltd. | Gastrointestinal, skin and immune | Apr 30, 2009 | 24 mo later |
| Apr 22, 2011 | MirceraEpoetin beta pegol (genetical recombination) | Chugai Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Apr 22, 2011 | ExelonRivastigmine | Ono Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | Apr 21, 2000 | 132 mo later |
| Apr 22, 2011 | LixianaEdoxaban tosilate hydrate | Daiichi Sankyo Company, Limited | Heart, Parkinson's and Alzheimer's | Jan 8, 2015 | 45 mo earlier |
| Apr 22, 2011 | LexaproEscitalopram oxalate | Not listed | Nervous system | Aug 14, 2002 | 104 mo later |
| Apr 22, 2011 | SupraneDesflurane | Baxter Limited | Anesthesia, eye and narcotics | No US match | — |
| Apr 22, 2011 | HalavenEribulin mesylate | Eisai Co., Ltd. | Cancer | Nov 15, 2010 | 5 mo later |
| Mar 23, 2011 | Novolin R FlexPen Novolin RInsulin human (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Jun 20, 2019 | 99 mo earlier |
| Feb 23, 2011 | NorspanBuprenorphine | Mundipharma K.K. | Anesthesia, eye and narcotics | Oct 8, 2002 | 101 mo later |
| Jan 21, 2011 | MemaryMemantine hydrochloride | Daiichi Sankyo Company, Limited | Heart, Parkinson's and Alzheimer's | Oct 16, 2003 | 87 mo later |
| Jan 21, 2011 | ReminylGalantamine hydrobromide | Janssen Pharmaceutical K.K. | Heart, Parkinson's and Alzheimer's | Feb 28, 2001 | 119 mo later |
| Jan 21, 2011 | PrazaxaDabigatran etexilate methanesulfonate | Nippon Boehringer Ingelheim Co., Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jan 21, 2011 | RomiplateRomiplostim (genetical recombination) | Kyowa Hakko Kirin Co., Ltd. | Heart, Parkinson's and Alzheimer's | Aug 22, 2008 | 29 mo later |
| Jan 21, 2011 | NerblocBotulinum toxin type B | Eisai Co., Ltd. | Nervous system | Dec 8, 2000 | 121 mo later |
| Jan 21, 2011 | StelaraUstekinumab (genetical recombination) | Janssen Pharmaceutical K.K. | Respiratory and allergy | Sep 25, 2009 | 16 mo later |
| Jan 21, 2011 | SurepostRepaglinide | Dainippon Sumitomo Pharma Co., Ltd. | Hormones and metabolism | No US match | — |
| Jan 21, 2011 | FeburicFebuxostat | Teijin Pharma Limited | Hormones and metabolism | Feb 13, 2009 | 23 mo later |
| Jan 21, 2011 | EdirolEldecalcitol | Chugai Pharmaceutical Co., Ltd. | Hormones and metabolism | No US match | — |
| Jan 21, 2011 | VidazaAzacitidine | Nippon Shinyaku Co., Ltd. | Cancer | May 19, 2004 | 80 mo later |
| Jan 17, 2011 | EncevacFreeze-dried, cell culture- derived Japanese encephalitis vaccine （inactivated） | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Biologics | No US match | — |
| Jan 14, 2011 | Freeze-dried Live Attenuated Measles, Rubella Combined VaccineFreeze-dried live attenuated measles, rubella combined vaccine | The Kitasato Institute | Biologics | No US match | — |
| Oct 27, 2010 | RadiogardaseIron(III)hexacyanoferrate(I I) | Nihon Medi-Physics Co., Ltd. | Gastrointestinal, skin and immune | No US match | — |
| Oct 27, 2010 | SamscaTolvaptan | Otsuka Pharmaceutical Co., Ltd. | Heart, Parkinson's and Alzheimer's | May 19, 2009 | 17 mo later |
| Oct 27, 2010 | RevoladeEltrombopag olamine | GlaxoSmithKline K.K. | Heart, Parkinson's and Alzheimer's | Nov 20, 2008 | 23 mo later |
| Oct 27, 2010 | InvegaPaliperidone | Janssen Pharmaceutical K.K. | Nervous system | Dec 19, 2006 | 46 mo later |
| Oct 27, 2010 | NevanacNepafenac | Alcon Japan Ltd. | Respiratory and allergy | Aug 19, 2005 | 62 mo later |
| Oct 27, 2010 | XyzalLevocetirizine hydrochloride | GlaxoSmithKline K.K. | Respiratory and allergy | May 25, 2007 | 41 mo later |
| Oct 27, 2010 | ByettaExenatide | Eli Lilly Japan K.K. | Hormones and metabolism | No US match | — |
| Oct 27, 2010 | TreakisymBendamustine hydrochloride | SymBio Pharmaceuticals Limited | Cancer | Mar 20, 2008 | 31 mo later |
| Oct 27, 2010 | Adsorbed Pandemic Influenza VaccineInactivated influenza virus, H5N1 (whole virion) | Kaketsuken [The Chemo-Sero-Therapeutic Research Institute] | Biologics | No US match | — |
| Sep 10, 2010 | InavirLaninamivir octanoate hydrate | Daiichi Sankyo Company, Limited | Infections | No US match | — |
| Jul 23, 2010 | VolibrisAmbrisentan | GlaxoSmithKline K.K. | Heart, Parkinson's and Alzheimer's | Jun 15, 2007 | 37 mo later |
| Jul 23, 2010 | E KeppraLevetiracetam | UCB Japan Co., Ltd. | Nervous system | Nov 30, 1999 | 128 mo later |
| Jul 23, 2010 | YazDrospirenone/ethinylestra diol betadex | Bayer Yakuhin, Ltd. | Reproductive and urinary | No US match | — |
| Jul 23, 2010 | OrenciaAbatacept (genetical recombination) | Bristol-Myers K.K. | Respiratory and allergy | Dec 23, 2005 | 55 mo later |
| Jul 23, 2010 | Synvisc IntraarticularSodium hyaluronate crosslinked polymer and sodium hyaluronate crosslinked polymer crosslinked with vinylsulfone | Genzyme Japan K.K. | Respiratory and allergy | No US match | — |
| Jul 23, 2010 | Forteo S.C.Teriparatide (genetical recombination) | Eli Lilly Japan K.K. | Hormones and metabolism | Nov 26, 2002 | 92 mo later |
| Jul 23, 2010 | ViviantBazedoxifene acetate | Pfizer Japan Inc. | Hormones and metabolism | No US match | — |
| Jul 23, 2010 | ToriselTemsirolimus | Pfizer Japan Inc. | Cancer | May 30, 2007 | 38 mo later |
| Jun 25, 2010 | RevlimidLenalidomide hydrate | Celgene K.K. | Cancer | Dec 27, 2005 | 54 mo later |
| Apr 16, 2010 | SolirisEculizumab (genetical recombination) | Alexion Pharma K.K. (currently Alexion Pharma G.K.) | Gastrointestinal, skin and immune | Mar 16, 2007 | 37 mo later |
| Apr 16, 2010 | RozeremRamelteon | Takeda Pharmaceutical Company Limited | Nervous system | Jul 22, 2005 | 57 mo later |
| Apr 16, 2010 | LyricaPregabalin | Pfizer Japan Inc. | Nervous system | Dec 30, 2004 | 64 mo later |
| Apr 16, 2010 | DiquasDiquafosoI sodium | Santen Pharmaceutical Co., Ltd. | Respiratory and allergy | No US match | — |
| Apr 16, 2010 | NesinaAlogliptin benzoate | Takeda Pharmaceutical Company Limited | Hormones and metabolism | Jan 25, 2013 | 33 mo earlier |
| Apr 16, 2010 | VectibixPanitumumab (genetical recombination） | Takeda Bio Development Center Limited | Cancer | No US match | — |
| Jan 20, 2010 | AloxiPalonosetron hydrochloride | Taiho Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Jul 25, 2003 | 78 mo later |
| Jan 20, 2010 | CymbaltaDuloxetine hydrochloride | Shionogi & Co., Ltd. | Nervous system | Aug 3, 2004 | 66 mo later |
| Jan 20, 2010 | BridionSugammadex sodium | Schering-Plough K.K. | Anesthesia, eye and narcotics | Dec 15, 2015 | 71 mo earlier |
| Jan 20, 2010 | EquaVildagliptin | Novartis Pharma K.K. | Hormones and metabolism | No US match | — |
| Jan 20, 2010 | VictozaLiraglutide (genetical recombination) | Novo Nordisk Pharma Ltd. | Hormones and metabolism | Jan 25, 2010 | Same month |
| Jan 13, 2010 | RapiactaPeramivir hydrate | Shionogi & Co., Ltd. | Infections | Dec 19, 2014 | 59 mo earlier |
| Oct 16, 2009 | EmendAprepitant | Ono Pharmaceutical Co., Ltd. | Gastrointestinal, skin and immune | Mar 26, 2003 | 79 mo later |
| Oct 16, 2009 | ErizasDexamethasone cipecilate | Nippon Shinyaku Co., Ltd. | Respiratory and allergy | No US match | — |
| Oct 16, 2009 | JanuviaSitagliptin phosphate hydrate | Ono Pharmaceutical Co., Ltd. | Hormones and metabolism | Oct 16, 2006 | 36 mo later |
| Oct 16, 2009 | BeneFIXNonacog alfa (genetical recombination) | Wyeth K.K. | Blood products | No US match | — |
| Oct 16, 2009 | MiriplaMiriplatin hydrate | Dainippon Sumitomo Pharma Co., Ltd. | Cancer | No US match | — |
| Oct 16, 2009 | RasuritekRasburicase (genetical recombination) | Sanofi-Aventis K.K. | Cancer | Jul 12, 2002 | 87 mo later |
| Oct 16, 2009 | CervarixHPV-16 L1 VLP and HPV-18 L1 VLP | GlaxoSmithKline K.K. | Biologics | No US match | — |
| Oct 16, 2009 | PrevenarPneumococcal polysaccharide (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F)- CRM conjugate 197 Inactivated split-virus influenza A (A/California/7/2009 [H1N1]) Pandemic influenza virus surface antigens of A/California/7/2009 (H1N1) like strain | Novartis Pharma K.K. | Biologics | No US match | — |
| Jul 7, 2009 | RasilezAliskiren fumarate | Novartis Pharma K.K. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Jul 7, 2009 | RemeronMirtazapine | Meiji Seika Kaisha, Ltd. | Nervous system | Jan 12, 2001 | 102 mo later |
| Jul 7, 2009 | LumiganBimatoprost | Senju Pharmaceutical Co., Ltd. | Anesthesia, eye and narcotics | Mar 16, 2001 | 100 mo later |
| Jul 7, 2009 | AvolveDutasteride | GlaxoSmithKline K.K. | Reproductive and urinary | Nov 20, 2001 | 92 mo later |
| Apr 22, 2009 | StratteraAtomoxetine hydrochloride | Eli Lilly Japan K.K. | Nervous system | Nov 26, 2002 | 77 mo later |
| Apr 22, 2009 | ClozarilClozapine | Novartis Pharma K.K. | Nervous system | Feb 10, 2004 | 62 mo later |
| Apr 22, 2009 | Orapenem FineTebipenem pivoxil | Meiji Seika Kaisha, Ltd. | Infections | Jun 17, 2026 | 206 mo earlier |
| Apr 22, 2009 | AllermistFluticasone furoate | GlaxoSmithKline K.K. | Respiratory and allergy | Apr 27, 2007 | 24 mo later |
| Apr 22, 2009 | ApidraInsulin glulisine (genetical recombination) | Not listed | Hormones and metabolism | No US match | — |
| Apr 22, 2009 | TykerbLapatinib tosilate hydrate | GlaxoSmithKline K.K. | Cancer | No US match | — |
| Feb 23, 2009 | Jebik VInactivated Japanese encephalitis virus (Beijing strain) | Research Foundation for Microbial Diseases of Osaka University | Biologics | No US match | — |
| Jan 21, 2009 | RemitchNalfurafine hydrochloride | Toray Industries, Inc. | Nervous system | No US match | — |
| Jan 21, 2009 | LucentisRanibizumab (genetical recombination) | Novartis Pharma K.K. | Nervous system | Jun 30, 2006 | 31 mo later |
| Jan 21, 2009 | XolairOmalizumab (genetical recombination) | Novartis Pharma K.K. | Respiratory and allergy | Jun 20, 2003 | 67 mo later |
| Jan 21, 2009 | RecalbonMinodronic acid hydrate, | Astellas Pharma Inc. | Hormones and metabolism | No US match | — |
| Jan 21, 2009 | TasignaNilotinib hydrochloride hydrate | Novartis Pharma K.K. | Cancer | Oct 29, 2007 | 15 mo later |
| Jan 21, 2009 | SprycelDasatinib hydrate | Bristol-Myers K.K. | Cancer | Jun 28, 2006 | 31 mo later |
| Dec 25, 2008 | IntelenceEtravirine | Janssen Pharmaceutical K.K. | HIV | Jan 18, 2008 | 11 mo later |
| Dec 25, 2008 | CelsentriMaraviroc | Pfizer Japan Inc. | HIV | Aug 6, 2007 | 17 mo later |
| Oct 16, 2008 | Fosrenol Chewablelanthanum carbonate hydrate | Bayer Yakuhin Ltd. | Gastrointestinal, skin and immune | Oct 26, 2004 | 48 mo later |
| Oct 16, 2008 | LamictalLamotrigine | GlaxoSmithKline K.K. | Nervous system | Aug 24, 1998 | 122 mo later |
| Oct 16, 2008 | TaprosTafluprost | Santen Pharmaceutical Co., Ltd. | Nervous system | Feb 10, 2012 | 40 mo earlier |
| Oct 16, 2008 | PirespaPirfenidone | Shionogi & Co., Ltd. | Respiratory and allergy | Oct 15, 2014 | 72 mo earlier |
| Oct 16, 2008 | ThaledThalidomide | Fujimoto Pharmaceutical Corporation | Cancer | Jul 16, 1998 | 123 mo later |
| Oct 16, 2008 | Thyrogen IMThyrotropin human alfa (genetical recombination) | Sato Pharmaceutical Co., Ltd. | Diagnostic agents | No US match | — |
| Jul 16, 2008 | DifferinAdapalene | Galderma S.A. | Gastrointestinal, skin and immune | May 26, 2000 | 98 mo later |
| Jul 16, 2008 | INOfloNitric oxide | INO therapeutics LLC | Heart, Parkinson's and Alzheimer's | Dec 23, 1999 | 103 mo later |
| Jul 16, 2008 | Macugen IvtPegaptanib sodium | Pfizer Japan Inc. | Nervous system | Sep 17, 2004 | 46 mo later |
| Jul 16, 2008 | MycobutinRifabutin | Pfizer Japan Inc. | Infections | No US match | — |
| Jul 16, 2008 | GanirestGanirelix acetate | Nippon Organon K.K. | Reproductive and urinary | Jul 29, 1999 | 108 mo later |
| Jul 16, 2008 | NasonexMometasone furoate hydrate | Schering-Plough K.K. | Respiratory and allergy | Mar 30, 2005 | 40 mo later |
| Jul 16, 2008 | ErbituxCetuximab (genetical recombination) | Merck KGaA | Cancer | Feb 12, 2004 | 53 mo later |
| Jul 16, 2008 | ThymoglobulineAnti-human thymocyte immunoglobulin, Rabbit | Sanofi-Aventis K.K. | Blood products | No US match | — |
| Jun 24, 2008 | IsentressRaltegravir potassium | Banyu Pharmaceutical Co., Ltd. | HIV | Oct 12, 2007 | 8 mo later |
| Apr 16, 2008 | Exjade DispersibleDeferasirox | Novartis Pharma K.K. | Gastrointestinal, skin and immune | Nov 2, 2005 | 29 mo later |
| Apr 16, 2008 | IrbetanIrbesartan | Dainippon Sumitomo Pharma Co., Ltd. | Heart, Parkinson's and Alzheimer's | No US match | — |
| Apr 16, 2008 | PopscaineLevobupivacaine hydrochloride | Maruishi Pharmaceutical Co., Ltd. | Nervous system | Aug 5, 1999 | 104 mo later |
| Apr 16, 2008 | FamvirFamciclovir | Asahi Kasei Pharma Corporation | Infections | No US match | — |
| Apr 16, 2008 | HumiraAdalimumab (genetical recombination) | Abbott Japan Co., Ltd. | Respiratory and allergy | Dec 31, 2002 | 64 mo later |
| Apr 16, 2008 | AroglycemDiazoxide | Schering-plough K.K. | Hormones and metabolism | No US match | — |
| Apr 16, 2008 | SutentSunitinib malate | Pfizer Japan Inc. | Cancer | Jan 26, 2006 | 27 mo later |
Seikagaku Corporation
Bristol-Myers Squibb Company
Merck KGaAPMDA publishes its English list a few months behind its Japanese announcements. A new active ingredient is one PMDA's notes call new; the US match is by ingredient name, ignoring salts, so vaccines and blood products (licensed by FDA's biologics center, not in Drugs@FDA), US approvals before 1998, drugs never approved in the US and a few differently named ingredients (adrenaline for epinephrine) show no US match. Refreshed weekly. PMDA, List of Approved Drugs (English); FDA Drugs@FDA