Ulcerative Colitis

• FDA approval · 2024-03-28
  FDA Approved: MESALAMINE — Supplemental Application (Northstar Rx LLC.)

  The FDA approved a supplemental application for Mesalamine submitted by Northstar Rx LLC (ANDA).

• FDA approval · 2024-03-19
  FDA Approved: MESALAMINE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approves a supplemental application for Mesalamine from Alembic Pharmaceuticals Limited.

• FDA approval · 2024-03-18
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab submitted by Janssen Biotech, Inc.

• FDA approval · 2024-03-14
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc. The action updates the p…

• FDA approval · 2024-03-14
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc., approving a modification to the…

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• FDA approval · 2024-03-01
  FDA Approved: MESALAMINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Mesalamine from Mylan Pharmaceuticals Inc. The action grants a supplemental approval for this ge…

• FDA approval · 2024-02-23
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2024-02-23
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ENTYVIO (vedolizumab) submitted by Takeda Pharmaceuticals America, Inc.

• FDA approval · 2024-02-22
  FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)

  The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.

• FDA approval · 2024-02-16
  FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for balsalazide disodium filed by Apotex Corp.

• FDA approval · 2024-02-16
  FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for balsalazide disodium submitted by Zydus Lifesciences Limited, marking approval of a supplement t…

• FDA approval · 2024-02-05
  FDA Approved: MESALAMINE — Original Application (NorthStar RxLLC)

  FDA approved the original ANDA for mesalamine submitted by NorthStar RxLLC, a generic formulation intended for the treatment of ulcerative c…

• FDA approval · 2024-01-31
  FDA Approved: MESALAMINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for mesalamine (generic), approving changes to an existing approved product.

• FDA approval · 2024-01-12
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Mesalamine filed by Zydus Lifesciences Limited under the ANDA pathway.

• FDA approval · 2023-12-26
  FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• FDA approval · 2023-12-11
  FDA Approved: MESALAMINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for mesalamine from Upsher-Smith Laboratories, LLC, as part of an Abbreviated New Drug Application.

• FDA approval · 2023-12-05
  FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)

  FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…

• FDA approval · 2023-11-30
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…

• FDA approval · 2023-11-27
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for mesalamine from Zydus Lifesciences Limited, authorizing changes described in the submission.

• FDA approval · 2023-11-07
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Mesalamine from Zydus Lifesciences Limited, updating its labeling.

• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.

• FDA approval · 2023-10-31
  FDA Approved: WEZLANA — Original Application (Nuvaila Limited)

  This entry documents the original Biologics License Application for WEZLANA, a ustekinumab-AUUB monoclonal antibody developed by Nuvaila Lim…

• FDA approval · 2023-10-26
  FDA Approved: OMVOH — Original Application (Eli Lilly and Company)

  FDA approved OMVOH (mirikizumab-mrkz) from Eli Lilly through an Original Biologics License Application, authorizing its marketing. This is t…