Amikacin Sulfate

Treats Mycobacterium avium complex (MAC) lung disease. Sold as Amikin, Amikin In Sodium Chloride 0.9% In Plastic Container, Arikayce. Every FDA application for this active ingredient: 3 branded and 23 generic.

As of Nov 15, 2026, FDA lists 26 applications for Amikacin Sulfate (sold as Amikin, Amikin In Sodium Chloride 0.9% In Plastic Container, Arikayce), first approved Sep 28, 2018, with 1 new use approved and 0 published complete response letters.

First approved: Sep 28, 2018
Applications: 26
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $910K
First approved in the EU: Oct 27, 2020

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Amikacin Sulfate	Part D	$893K	-15%	2,539
Amikacin Sulfate	Part B	$17K	-44%	1,644

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Management of cystic fibrosis patients with Pseudomonas aeruginosa lung infectionsPlumeStars s.r.l. · designated Jan 5, 2015

Approvals in the EU (EMA)

First approved in the EU 25 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Arikayce liposomal, new substanceInsmed Netherlands B.V. · Oct 27, 2020

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Arikayce inhalation solution, new approvalA drug with a new route of administration indicated for the treatment of nontuberculous mycobacterial pulmonary disease caused by amikacin-sensitive… · Insmed GK · Mar 23, 2021

Clinical Trials

24 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular MassAppendicular Mass, Acute Appendicitis · Assiut University	Not applicable	Not yet recruiting	Sep 23, 2026
Efficacy and Safety of Bronchoscopic Local Amikacin Instillation for Acute Exacerbations of Bronchiectasis in Adults: A Multicenter, Blinded, Randomized Controlled TrialBronchiectasis With Acute Exacerbation · First Affiliated Hospital of Ningbo University	Not applicable	Recruiting	Sep 10, 2026
Colistin and Meropenem Versus Amikacin and Meropenem for MDR Gram Negative Bacteria Regarding Efficacy and Safety.MDR Bacteria · Beni-Suef University	Phase 4	Active, not recruiting	Jul 10, 2026
Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated TracheobronchitisVentilator-Associated Pneumonia, Ventilator-Associated Tracheobronchitis · University Hospital, Tours	Phase 3	Not yet recruiting	Jun 24, 2026
Early Discontinuation of Antibiotics in Paediatric High-risk Febrile NeutropeniaFebrile Neutropenia (FN), Pediatric Cancer · Hospital Universitari Vall d'Hebron Research Institute	Phase 4	Not yet recruiting	May 15, 2026
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin ResistanceMycobacterium Abscessus Lung Disease · National Taiwan University Hospital	Phase 4	Recruiting	Apr 7, 2026
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform TrialMycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection · The University of Queensland	Phase 2	Not yet recruiting	Mar 20, 2026
Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of CareFebrile Urinary Tract Infection · Uppsala University	Phase 4	Recruiting	Nov 19, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 22, 1981	AmikinANDA 62311	Apothecon	16	Discontinued
May 18, 1992	Amikacin SulfateANDA 63274	Hikma	2	Discontinued
May 18, 1992	Amikacin SulfateANDA 63275	Hikma	3	Discontinued
Jul 30, 1993	Amikacin SulfateANDA 63350	Hospira	3	Discontinued
Sep 28, 1993	Amikacin SulfateANDA 64045	Meitheal	8	Marketed
Apr 11, 1994	Amikacin SulfateANDA 63313	Hikma	5	Marketed
Apr 11, 1994	Amikacin SulfateANDA 63315	Hikma	6	Marketed
Oct 28, 1994	Amikacin SulfateANDA 63266	Abbott	0	Discontinued
Oct 31, 1994	Amikacin SulfateANDA 63283	Hospira	4	Discontinued
Nov 30, 1994	Amikacin SulfateANDA 63263	Hospira	10	Discontinued
Nov 30, 1994	Amikacin SulfateANDA 63264	Hospira	10	Discontinued
Nov 30, 1994	Amikacin SulfateANDA 63265	Abbott	0	Discontinued
Jun 20, 1995	Amikacin SulfateANDA 64099	Hospira	1	Discontinued
Jun 26, 1995	Amikacin SulfateANDA 64098	Hospira	1	Discontinued
Apr 2, 1997	Amikacin Sulfate In Sodium Chloride 0.9% In Plastic ContainerANDA 64146	Hospira	2	Discontinued
Dec 12, 2013	Amikacin SulfateANDA 204040	Avet Lifesciences	5	Marketed
Dec 9, 2015	Amikacin SulfateANDA 205604	Fresenius Kabi USA	4	Marketed
Dec 9, 2015	Amikacin SulfateANDA 205605	Fresenius Kabi USA	0	Discontinued
May 12, 2016	Amikacin SulfateANDA 203323	Sagent Pharms Inc	2	Marketed
Sep 28, 2018	ArikayceNDA 207356 · New dosage form	Insmed Inc	6	Marketed
Mar 19, 2024	Amikacin SulfateANDA 218146	Qilu	0	Marketed
—	AmikinANDA 62562	Apothecon	0	Discontinued
—	Amikacin SulfateANDA 63167	Igi Labs Inc	0	Discontinued
—	Amikacin SulfateANDA 63169	Igi Labs Inc	0	Discontinued
—	AmikinNDA 50495	Apothecon	0	Discontinued
—	Amikin In Sodium Chloride 0.9% In Plastic ContainerNDA 50618	Apothecon	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA