Tools / Drug approvals and letters / Drugs Mesalamine Treats active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis. Sold as Rowasa, Sfrowasa, Asacol, Pentasa, Canasa and 4 more. Every FDA application for this active ingredient: 9 branded and 36 generic.
As of Nov 13, 2026, FDA lists 45 applications for Mesalamine (sold as Rowasa, Sfrowasa, Asacol and others), first approved Dec 24, 1987, with 10 new uses approved and 0 published complete response letters.
First approved : Dec 24, 1987 Applications : 45 New uses approved : 10 Complete response letters : 0 Medicare spending, 2025 : $114M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Pentasa Part D $33.3M +11% 4,938 Mesalamine ER Part D $26.6M -35% 27,183 Apriso Part D $24.6M +370% 6,415 Mesalamine Dr Part D $22.7M +3% 9,948 Lialda Part D $6.1M -13% 900 Canasa Part D $1.1M -7% 152 Sfrowasa Part D $54K +67% 19 Delzicol Part D $6K -99% 0
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 28 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Conventional vs Biologic Therapy in Pediatric IBD Inflammatory Bowel Diseases, Crohn Disease · Assiut University — Not yet recruiting Sep 14, 2026 Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease Crohn Disease and Ulcerative Colitis · Anabio R&D Not applicable Recruiting Sep 2, 2026 Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis Ulcerative Colitis (UC) · Allama Iqbal Medical College Phase 1 / Phase 2 Enrolling by invitation Aug 26, 2026 Comaprison of Efficacy and Safety Between Etrasimod vs Mesalazine in Chinese Adults With Active UC Etrasimod, Mesalazine · Sir Run Run Shaw Hospital Phase 4 Not yet recruiting Aug 24, 2026 ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery Ulcerative Colitis (UC), Pouchitis · University Hospital, Linkoeping Phase 4 Not yet recruiting Aug 19, 2026 ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea Diarrhea Chronic, UC - Ulcerative Colitis · The Second Hospital of Nanjing Medical University Early phase 1 Recruiting Aug 17, 2026 AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD) · ENBIOSIS BIOTECHNOLOGIES Not applicable Not yet recruiting Jun 2, 2026 Palmitoylethanolamide in Ulcerative Colitis Ulcerative Colitis (UC) · Ain Shams University Not applicable Recruiting May 27, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Dec 24, 1987 Rowasa, Sfrowasa NDA 19618 · New molecular entity 20 Marketed Dec 18, 1990 Rowasa NDA 19919 · New dosage form 3 Discontinued Jan 31, 1992 Asacol NDA 19651 · New dosage form 21 Discontinued May 10, 1993 Pentasa NDA 20049 · New dosage form 27 Marketed Jan 5, 2001 Canasa NDA 21252 · New formulation or manufacturer 18 Marketed Sep 17, 2004 Mesalamine ANDA 76751 2 Marketed Sep 30, 2004 Mesalamine ANDA 76841 1 Discontinued Jan 16, 2007 Lialda NDA 22000 · New dosage form 21 Marketed May 29, 2008 Asacol Hd NDA 21830 · New dosage form 12 Discontinued Oct 31, 2008 Apriso NDA 22301 · New dosage form 10 Marketed Feb 1, 2013 Delzicol NDA 204412 · New dosage form 12 Discontinued Nov 24, 2015 Mesalamine ANDA 204354 6 Marketed Jun 5, 2017 Mesalamine ANDA 91640 14 Marketed Jul 21, 2017 Mesalamine ANDA 203286 11 Marketed Mar 23, 2018 Mesalamine ANDA 203817 7 Marketed Nov 20, 2018 Mesalamine ANDA 203574 1 Discontinued Jan 25, 2019 Mesalamine ANDA 211858 7 Marketed Apr 19, 2019 Mesalamine ANDA 207448 0 Marketed May 9, 2019 Mesalamine ANDA 207873 5 Marketed Jun 12, 2019 Mesalamine ANDA 202065 4 Marketed Jun 21, 2019 Mesalamine ANDA 208362 0 Marketed Nov 20, 2019 Mesalamine ANDA 207271 4 Marketed Jan 2, 2020 Mesalamine ANDA 210509 4 Discontinued Feb 12, 2020 Mesalamine ANDA 208953 4 Marketed Mar 19, 2020 Mesalamine ANDA 213377 2 Marketed Aug 14, 2020 Mesalamine ANDA 205654 4 Marketed Jul 15, 2021 Mesalamine ANDA 214242 3 Marketed Aug 12, 2021 Mesalamine ANDA 208954 3 Marketed May 6, 2022 Mesalamine ANDA 209970 0 Discontinued May 11, 2022 Mesalamine ANDA 214585 2 Marketed Oct 28, 2022 Mesalamine ANDA 216967 2 Marketed Mar 31, 2023 Mesalamine ANDA 214477 1 Marketed May 12, 2023 Mesalamine ANDA 217337 1 Marketed May 30, 2023 Mesalamine ANDA 216941 2 Marketed Jun 6, 2023 Mesalamine ANDA 217533 1 Marketed Feb 5, 2024 Mesalamine ANDA 216334 0 Marketed Aug 22, 2024 Mesalamine ANDA 213191 1 Marketed Aug 22, 2024 Mesalamine ANDA 218410 0 Marketed Feb 18, 2025 Mesalamine ANDA 215067 1 Marketed Apr 14, 2025 Mesalamine ANDA 219028 0 Marketed Apr 16, 2025 Mesalamine ANDA 215269 0 Marketed Aug 13, 2025 Mesalamine ANDA 219864 0 Marketed Mar 10, 2026 Mesalamine ANDA 219997 0 Marketed Mar 31, 2026 Mesalamine ANDA 220016 0 Marketed Oct 13, 2026 Mesalamine ANDA 217736 0 Marketed
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
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