Crohn Disease

• FDA approval · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for azathioprine from Rising Pharma Holdings, Inc., confirming a new generic form of the drug.

• FDA approval · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …

• FDA approval · 2018-10-30
  FDA Approved: ADALIMUMAB — Original Application (Sandoz Inc)

  FDA approved the original application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc. The approval covers the same indication…

• FDA approval · 2018-10-16
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2018-07-03
  FDA Approved: BUDESONIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Budesonide from Actavis Pharma, Inc. (ANDA205457).

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• FDA approval · 2018-06-08
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2018-05-30
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2018-05-23
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)

  The FDA approved a supplemental application for mercaptopurine from Florida Pharmaceutical Products, LLC.

• FDA approval · 2018-04-18
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA approved Biogen's supplemental application for TYSABRI (natalizumab).

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2018-02-16
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• EMA approval · 2017-12-15
  New medicine to treat perianal fistulas in patients with Crohn's disease

  The EMA announces a new medicine approved to treat perianal fistulas in adults with Crohn's disease.

• FDA approval · 2017-10-17
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for Budesonide submitted by Padagis US LLC, expanding regulatory authorization for the product. The …

• FDA approval · 2017-10-13
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., potentially expanding indications or updat…

• FDA approval · 2017-08-16
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen's supplemental application for TYSABRI (natalizumab), resulting in changes to the drug's labeling.

• FDA approval · 2017-07-31
  FDA Approved: BUDESONIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal Pharmaceuticals of New York LLC's original application for budesonide (generic). Budesonide is a corticosteroid used to …

• FDA approval · 2017-07-27
  FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for mesalamine filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2017-07-27
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Mesalamine from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2017-06-05
  FDA Approved: MESALAMINE — Original Application (Zydus Lifesciences Limited)

  FDA approved the original application for mesalamine from Zydus Lifesciences Limited, confirming the generic product for inflammatory bowel …

• FDA approval · 2017-04-21
  FDA Approved: RENFLEXIS — Original Application (Organon LLC)

  The FDA approved RENFLEXIS (infliximab) from Organon LLC based on an original application, making it a biosimilar to Remicade. The approval …

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2016-04-29
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for budesonide. The action reflects changes to the product's labeling…

• FDA approval · 2016-04-05
  FDA Approved: INFLECTRA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved INFLECTRA (infliximab-dyyb) as a biosimilar to infliximab for multiple autoimmune diseases, expanding access to a biologic ther…

• FDA approval · 2016-03-08
  FDA Approved: BUDESONIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a generic budesonide product under an Original Application (ANDA 204548) for Teva Pharmaceuticals USA, Inc. This marks the appr…

• FDA approval · 2015-11-30
  FDA Approved: BUDESONIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Budesonide from Chartwell RX, LLC, authorizing a change to an existing generic product.