Crohn Disease

• FDA approval · 2024-07-09
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)

  The FDA approved a supplemental application for mercaptopurine (Purixan) by Nova Laboratories, Ltd., updating the product labeling and/or in…

• FDA approval · 2024-07-09
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  FDA approved a supplemental application for Mercaptopurine submitted by Florida Pharmaceutical Products, LLC.

• FDA approval · 2024-06-28
  FDA Approved: USTEKINUMAB-TTWE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approves a new biologic product, ustekinumab-tTWE, from Quallent Pharmaceuticals Health LLC, via an Original Biologics License Applicati…

• FDA approval · 2024-04-30
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…

• FDA approval · 2024-04-18
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Entyvio (vedolizumab) from Takeda Pharmaceuticals America, Inc., to modify labeling and expa…

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• FDA approval · 2024-04-18
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Entyvio (vedolizumab) from Takeda Pharmaceuticals America, resulting in a labeling update fo…

• FDA approval · 2024-04-16
  FDA Approved: SELARSDI — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved SELARSDI (USTEKINUMAB-AEKN) from Teva Pharmaceuticals USA, Inc. under an original Biologics License Application (BLA 761343).

• FDA approval · 2024-04-12
  FDA Approved: MESALAMINE — Supplemental Application (Encube Ethicals, Inc.)

  FDA approved a supplemental application for Mesalamine from Encube Ethicals, Inc.

• FDA approval · 2024-04-04
  FDA Approved: MESALAMINE — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Mesalamine submitted by Ascend Laboratories, LLC.

• 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…

• 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 · 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 · 2023-12-05
  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 · 2023-11-08
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for CIMZIA (certolizumab pegol) from UCB, Inc., updating its labeling and/or indications.

• 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.