Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-10-24FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for CANASA (mesalamine) submitted by Allergan, Inc.
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FDA approval · 2023-10-24FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-10-24FDA 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 · 2023-10-24FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for Mesalamine from ANI Pharmaceuticals, Inc., resulting in updated labeling for the product.
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FDA approval · 2023-10-24FDA 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 · 2023-10-24FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, Inc., enabling changes to its labe…
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FDA approval · 2023-10-20FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)
FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…
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FDA approval · 2023-10-12FDA Approved: VELSIPITY — Original Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved VELSIPITY (etrasimod) from Pfizer as a new therapy for ulcerative colitis.
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FDA approval · 2023-09-27FDA Approved: ENTYVIO — Original Application (Takeda Pharmaceuticals America, Inc.)
ENTYVIO (vedolizumab) received FDA approval under the original application by Takeda Pharmaceuticals America for the treatment of adult pati…
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FDA approval · 2023-09-21FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…
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FDA approval · 2023-09-20FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for mesalamine by Teva Pharmaceuticals USA, Inc., marking an update to its labeling.
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FDA approval · 2023-09-12FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries Inc.)
FDA approved a supplemental application for mesalamine submitted by Sun Pharmaceutical Industries Inc.
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FDA approval · 2023-09-12FDA Approved: MESALAMINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Mesalamine from Camber Pharmaceuticals, indicating an approved change to an existing generic pro…
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FDA approval · 2023-08-25FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for mesalamine from Sun Pharmaceutical Industries, updating the product labeling.
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FDA approval · 2023-08-24FDA Approved: SULFASALAZINE — Supplemental Application (Chartwell RX, LLC.)
FDA approved a supplemental application for the generic drug sulfasalazine submitted by Chartwell RX, LLC.
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FDA approval · 2023-08-08FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for balsalazide disodium from Hikma Pharmaceuticals USA Inc. under ANDA 077806, enabling continued m…
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FDA approval · 2023-08-07FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Mesalamine (Actavis Pharma, Inc.), allowing continued marketing of Mesalamine products.
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FDA approval · 2023-08-07FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited.
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FDA approval · 2023-06-30FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
The FDA approved a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC.
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FDA approval · 2023-06-14FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for ABRILADA (adalimumab-afzb) submitted by Pfizer Laboratories Div Pfizer Inc to update the labelin…
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FDA approval · 2023-06-08FDA Approved: BALSALAZIDE DISODIUM — Original Application (Zydus Lifesciences Limited)
FDA approves balsalazide disodium as a generic product under an original ANDA by Zydus Lifesciences Limited for the treatment of ulcerative …
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FDA approval · 2023-06-06FDA Approved: MESALAMINE — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved Upsher-Smith Laboratories, LLC's original application for mesalamine (a generic formulation).
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FDA approval · 2023-05-30FDA Approved: MESALAMINE — Original Application (Encube Ethicals, Inc.)
FDA approved an original ANDA for mesalamine (Encube Ethicals, Inc.), a generic formulation.
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FDA approval · 2023-05-23FDA Approved: ADALIMUMAB — Original Application (CELLTRION USA, Inc.)
FDA approved ADALIMUMAB-AATY from CELLTRION USA, Inc. as a biosimilar to adalimumab under an Original Application for the same indications a…
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FDA approval · 2023-05-18FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar to adalimumab, from QUALLENT PHARMACEUTICALS HEALTH LLC.