Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-04-30FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for SELARSDI (ustekinumab-aekn) from Teva Pharmaceuticals USA, Inc., representing an approval of a b…
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FDA approval · 2025-04-30FDA Approved: OTULFI — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for OTULFI (ustekinumab-aauz) from Fresenius Kabi USA, LLC.
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FDA approval · 2025-04-30FDA Approved: STEQEYMA — Original Application (CELLTRION USA, Inc.)
The FDA approved STEQEYMA (ustekinumab-stba) from Celltrion USA, Inc. under an Original Biologics License Application.
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FDA approval · 2025-04-30FDA Approved: YESINTEK — Original Application (Biocon Biologics Inc.)
The FDA approved Yesintek (ustekinumab) from Biocon Biologics Inc. under an original Biologics License Application. It is indicated for plaq…
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FDA approval · 2025-04-30FDA Approved: OTULFI — Original Application (Fresenius Kabi USA, LLC)
OTULFI (USTEKINUMAB-AAUZ) received FDA approval under an Original Application from Fresenius Kabi USA, LLC.
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FDA approval · 2025-04-28FDA Approved: STEQEYMA — Supplemental Application (CELLTRION USA, Inc.)
The FDA approved a supplemental application for STEQEYMA (ustekinumab-stba) from Celltrion USA, Inc.
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FDA approval · 2025-04-14FDA Approved: OTULFI — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental Biologics License Application for OTULFI (ustekinumab-AAUZ) from Fresenius Kabi USA, LLC.
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FDA approval · 2025-04-14FDA Approved: MESALAMINE — Original Application (Rising Pharma Holdings, Inc.)
FDA approves the original Abbreviated New Drug Application for Mesalamine from Rising Pharma Holdings, Inc., establishing a generic version …
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FDA approval · 2025-04-07FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
FDA approved a supplemental application for ADALIMUMAB-AATY, a biosimilar adalimumab from Celltrion USA, Inc., in connection with its regula…
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FDA approval · 2025-04-03FDA Approved: BALSALAZIDE DISODIUM — Original Application (Carnegie Pharmaceuticals, LLC)
FDA approved the original ANDA for balsalazide disodium as a generic treatment for ulcerative colitis, manufactured by Carnegie Pharmaceutic…
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FDA approval · 2025-04-01FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ustekinumab (Stelara) by Janssen Biotech, Inc.
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FDA approval · 2025-03-26FDA Approved: RINVOQ — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Rinvoq (upadacitinib) from AbbVie, resulting in labeling changes to the product.
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FDA approval · 2025-03-13FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC, updating the product’s labeling a…
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FDA approval · 2025-03-06FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Mesalamine submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-02-21FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XELJANZ XR (tofacitinib) submitted by Pfizer, updating the extended-release formulation's label.
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FDA approval · 2025-02-18FDA Approved: MESALAMINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's original ANDA for Mesalamine, a generic mesalamine product. This approval authorizes marketing for ulcerative colitis,…
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FDA approval · 2025-02-13FDA Approved: PREDNISOLONE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental Abbreviated New Drug Application for a generic prednisolone product from PAI Holdings/PAI Pharma, signaling regu…
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FDA approval · 2025-02-12FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for SELARSDI (ustekinumab-aeKn) from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-01-23FDA Approved: MESALAMINE — Supplemental Application (Encube Ethicals, Inc.)
FDA approved a supplemental application for mesalamine submitted by Encube Ethicals, Inc.
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FDA approval · 2025-01-15FDA Approved: OMVOH — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for OMVOH (mirikizumab-MRKZ) submitted by Eli Lilly and Company.
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FDA approval · 2024-12-26FDA Approved: WEZLANA — Supplemental Application (Nuvaila Limited)
The FDA approved a supplemental Biologics License Application for WEZLANA (ustekinumab-auub) submitted by Nuvaila Limited.
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FDA approval · 2024-12-20FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC. This action confirms additional regul…
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FDA approval · 2024-12-18FDA Approved: IDACIO — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for IDACIO (adalimumab-aacf) from Fresenius Kabi USA, LLC.
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FDA approval · 2024-12-17FDA Approved: STEQEYMA — Original Application (CELLTRION USA, Inc.)
FDA approved STEQEYMA (ustekinumab-stba) from Celltrion USA as a biosimilar to ustekinumab under an original biologics license application. …
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FDA approval · 2024-11-29FDA Approved: YESINTEK — Original Application (Biocon Biologics Inc.)
FDA approved Yesintek (ustekinumab) from Biocon Biologics Inc. under an Original Application. It covers the established ustekinumab indicati…