Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-11-18FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for mesalamine by Zydus Lifesciences Limited, updating or expanding its labeling.
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FDA approval · 2021-11-01FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA has approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, resulting in an updated labeli…
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FDA approval · 2021-11-01FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)
FDA approves a supplemental application for CANASA (mesalamine) by Allergan, Inc.
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FDA approval · 2021-11-01FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) from Viatris Specialty LLC.
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FDA approval · 2021-11-01FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for mesalamine filed by ANI Pharmaceuticals, Inc.
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FDA approval · 2021-11-01FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves a supplemental application for mesalamine from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2021-11-01FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIALDA (mesalamine) submitted by Takeda Pharmaceuticals America, expanding the approved labeling…
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FDA approval · 2021-11-01FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Azulfidine EN-Tabs (sulfasalazine) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2021-10-15FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approves a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC. The approval…
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FDA approval · 2021-08-17FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2021-08-12FDA Approved: MESALAMINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original Abbreviated New Drug Application for mesalamine from Zydus Lifesciences Limited, adding a generic option for the tr…
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FDA approval · 2021-07-30FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for balsalazide disodium from Apotex Corp., enabling the generic product to be marketed.
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FDA approval · 2021-07-15FDA Approved: MESALAMINE — Original Application (Ascend Laboratories, LLC)
The FDA approved an original ANDA for mesalamine, authorizing Ascend Laboratories, LLC to market a generic version of the anti-inflammatory …
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FDA approval · 2021-06-25FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.
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FDA approval · 2021-06-17FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves a supplemental application for INFLECTRA (infliximab-dyyb) from Pfizer Laboratories Div Pfizer Inc, marking FDA action on a bio…
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FDA approval · 2021-05-27FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application to add a 7-day starter pack for ZEPOSIA (ozanimod hydrochloride), expanding dosing packaging for the…
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FDA approval · 2021-05-25FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Pentasa (mesalamine) submitted by Takeda Pharmaceuticals America.
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FDA approval · 2021-05-25FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc. LIALDA is indicated for ulcera…
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FDA approval · 2021-03-22FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Mesalamine from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2021-02-24FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)
FDA approval of a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc.
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FDA approval · 2021-01-29FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for mercaptopurine by Mylan Pharmaceuticals, updating the regulatory status for the marketed product…
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FDA approval · 2021-01-25FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for mercaptopurine submitted by Hikma Pharmaceuticals USA Inc., indicating changes to the product's …
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FDA approval · 2021-01-15FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for AZULFIDINE EN-TABS (sulfasalazine) from Pfizer, resulting in updated labeling and/or approved in…
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FDA approval · 2021-01-07FDA Approved: AZATHIOPRINE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for azathioprine sodium from Hikma Pharmaceuticals USA Inc., updating the generic product's approval…
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FDA approval · 2020-12-17FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, authorizing changes to the product labe…