Ulcerative Colitis

• FDA approval · 2019-07-25
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib extended-release), expanding its formulation under Pfizer's submission.

• 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 · 2019-07-18
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., resulting in updated labeling…

• FDA approval · 2019-07-16
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2019-06-21
  FDA Approved: MESALAMINE RECTAL — Original Application (Amring Pharmaceuticals Inc.)

  FDA approved Amring Pharmaceuticals' Mesalamine Rectal as an Original Application (ANDA 208362), authorizing a generic mesalamine rectal pro…

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• 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 · 2019-05-09
  FDA Approved: MESALAMINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva Pharmaceuticals USA, Inc.'s original application for mesalamine (mesalamine), granting a generic drug approval.

• 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.

• 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 · 2019-04-19
  FDA Approved: MESALAMINE — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings' original ANDA for Mesalamine, a generic formulation of the anti-inflammatory drug used to treat ulc…

• FDA approval · 2019-03-12
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Mesalamine from Teva Pharmaceuticals USA, Inc., updating the product labeling.

• 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 · 2019-01-25
  FDA Approved: MESALAMINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's generic Mesalamine as an original ANDA application.

• 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).

• FDA approval · 2018-06-26
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Mesalamine from Zydus Lifesciences Limited, resulting in updated labeling for the drug.

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

  The FDA approved a supplemental application for LIALDA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc., to update the product…

• 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 · 2018-03-23
  FDA Approved: MESALAMINE — Original Application (Actavis Pharma, Inc.)

  FDA approval of the original application (ANDA) for mesalamine, enabling its generic availability for the treatment of ulcerative colitis.

• 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.