Crohn Disease

• 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 · 2023-10-24
  FDA 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.

• FDA approval · 2023-10-20
  FDA 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…

• FDA approval · 2023-09-27
  FDA 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…

• FDA approval · 2023-09-21
  FDA 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 · 2023-09-12
  FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries Inc.)

  FDA approved a supplemental application for mesalamine submitted by Sun Pharmaceutical Industries Inc.

• FDA approval · 2023-08-24
  FDA Approved: SULFASALAZINE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for the generic drug sulfasalazine submitted by Chartwell RX, LLC.

• FDA approval · 2023-08-24
  FDA Approved: TYRUKO — Original Application (Sandoz Inc)

  FDA approved TYRUKO (natalizumab-sztn) from Sandoz Inc under an original Biologics License Application as a natalizumab biosimilar. The appr…

• FDA approval · 2023-06-30
  FDA 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.

• FDA approval · 2023-06-14
  FDA 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…

• FDA approval · 2023-05-23
  FDA 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…

• FDA approval · 2023-05-18
  FDA 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.

• FDA approval · 2023-04-14
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for adalimumab-adaz, a biosimilar to adalimumab, confirming its regulatory approval for use.

• FDA approval · 2023-04-11
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TYSABRI (natalizumab). The action updates the product labeling to reflect the requested c…

• FDA approval · 2023-03-31
  FDA Approved: YUSIMRY — Supplemental Application (Coherus BioSciences Inc)

  FDA approved a supplemental Biologics License Application for YUSIMRY (adalimumab-aqvh) by Coherus BioSciences, authorizing the biosimilar p…

• FDA approval · 2023-03-31
  FDA Approved: MESALAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the Original Application for Mesalamine from Aurobindo Pharma Limited (generic Mesalamine). Indications include inflammatory bo…

• FDA approval · 2023-03-06
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) to expand its indications, as requested by Janssen Biotech, Inc.

• FDA approval · 2023-01-25
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approves a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2022-12-13
  FDA Approved: IDACIO — Original Application (Fresenius Kabi USA, LLC)

  FDA approved IDACIO (adalimumab-afcf) from Fresenius Kabi USA, LLC as a biosimilar to adalimumab (Humira) under an original Biologics Licens…

• FDA approval · 2022-11-16
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine En-Tabs (sulfasalazine) filed by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2022-10-28
  FDA Approved: MESALAMINE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the original application for a generic MESALAMINE product by Alembic Pharmaceuticals Limited.

• FDA approval · 2022-07-18
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz's supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ. The approval covers multiple inflammatory …

• FDA approval · 2022-06-17
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2022-06-03
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for Mesalamine by Zydus Lifesciences Limited.

• FDA approval · 2021-12-17
  FDA Approved: YUSIMRY — Original Application (Coherus BioSciences Inc)

  FDA approved YUSIMRY (adalimumab-aqvh) from Coherus BioSciences in an original biologics license application, likely as a biosimilar to adal…