Ulcerative Colitis

• FDA approval · 2023-05-12
  FDA Approved: MESALAMINE — Original Application (Lannett Company Inc.)

  FDA approval of a generic mesalamine product from Lannett Company Inc. (Original Application).

• 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 · 2023-03-31
  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.

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• FDA approval · 2023-03-01
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for mesalamine from Zydus Lifesciences Limited, under an ANDA. The approval pertains to a generic pr…

• 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: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2022-11-16
  FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.

• 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 · 2022-11-16
  FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for MESALAMINE from ANI Pharmaceuticals, 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 · 2022-07-27
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for mesalamine from Zydus Lifesciences 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 · 2022-06-03
  FDA Approved: MESALAMINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for mesalamine filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2022-05-11
  FDA Approved: MESALAMINE — Original Application (Sun Pharmaceutical Industries Inc.)

  The FDA approved the original ANDA application for mesalamine from Sun Pharmaceutical Industries Inc., granting generic drug approval. The a…

• 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…

• FDA approval · 2021-12-15
  FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)

  The FDA approved a supplemental application to introduce a 7-day starter pack of Zeposia (ozanimod hydrochloride) for Celgene Corporation.

• FDA approval · 2021-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc. The submission status …

• FDA approval · 2021-12-14
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc, resulting in updated …

• 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 · 2021-12-02
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) from Pfizer Laboratories Div Pfizer Inc. The approval authorizes the ex…