Crohn Disease

• FDA approval · 2021-12-06
  FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Mesalamine from Actavis Pharma, Inc. (generic Mesalamine).

• FDA approval · 2021-11-01
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine EN-Tabs (sulfasalazine) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2021-10-15
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approves a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC. The approval…

• FDA approval · 2021-08-17
  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 · 2021-06-17
  FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for INFLECTRA (infliximab-dyyb) from Pfizer Laboratories Div Pfizer Inc, marking FDA action on a bio…

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• FDA approval · 2021-02-24
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approval of a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ from Sandoz Inc.

• FDA approval · 2021-01-29
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mercaptopurine by Mylan Pharmaceuticals, updating the regulatory status for the marketed product…

• FDA approval · 2021-01-25
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for mercaptopurine submitted by Hikma Pharmaceuticals USA Inc., indicating changes to the product's …

• FDA approval · 2021-01-15
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for AZULFIDINE EN-TABS (sulfasalazine) from Pfizer, resulting in updated labeling and/or approved in…

• FDA approval · 2021-01-07
  FDA Approved: AZATHIOPRINE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves a supplemental application for azathioprine sodium from Hikma Pharmaceuticals USA Inc., updating the generic product's approval…

• FDA approval · 2020-12-11
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab filed by Janssen Biotech, Inc. The action updates the product's labeling.

• FDA approval · 2020-12-01
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., reflecting an approval of changes to its label…

• FDA approval · 2020-07-15
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for budesonide submitted by Padagis US LLC. The approval updates the labeling for budesonide under t…

• FDA approval · 2020-07-06
  FDA Approved: HULIO — Original Application (Biocon Biologics Inc)

  FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…

• FDA approval · 2020-06-17
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  FDA supplemental approval application submitted for TYSABRI (natalizumab) by Biogen; seeks regulatory action on an additional indication or …

• FDA approval · 2020-04-07
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)

  FDA approved a supplemental application for Mercaptopurine (Purixan) submitted by Nova Laboratories, Ltd.

• FDA approval · 2020-03-31
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Entyvio (vedolizumab) submitted by Takeda Pharmaceuticals America, resulting in updated appr…

• FDA approval · 2020-02-12
  FDA Approved: MESALAMINE — Original Application (Northstar Rx LLC.)

  FDA approved an original application for mesalamine (generic) submitted by Northstar Rx LLC.

• FDA approval · 2019-12-06
  FDA Approved: AVSOLA — Original Application (Amgen, Inc)

  FDA approved AVSOLA (infliximab-axxq) from Amgen as a biosimilar to infliximab, for the same indications as the reference product.

• FDA approval · 2019-10-29
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide by Rite Aid Corporation, expanding or modifying the approval of this generic product.

• FDA approval · 2019-07-23
  FDA Approved: HADLIMA — Original Application (Organon LLC)

  FDA approves Hadlima (adalimumab-bwwd) from Organon as a biosimilar to Humira under the original application BLA761059. It is indicated for …

• FDA approval · 2019-06-13
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

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

• FDA approval · 2019-05-07
  FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2019-05-06
  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 · 2019-04-23
  FDA Approved: AZATHIOPRINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for azathioprine from Zydus Lifesciences Limited.