Ulcerative Colitis

• FDA approval · 2015-09-18
  FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  FDA granted a supplemental approval for sulfasalazine from Sunrise Pharmaceutical, Inc.

• FDA approval · 2015-08-05
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2015-06-19
  FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ (tofacitinib) submitted by Pfizer Laboratories Div Pfizer Inc. The approval updates the …

• FDA approval · 2015-06-08
  FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for balsalazide disodium filed by Apotex Corp., confirming regulatory approval for this generic prod…

• FDA approval · 2015-06-03
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for budesonide submitted by Teva Pharmaceuticals USA, Inc.

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• FDA approval · 2014-12-19
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for SIMPONI (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2014-10-16
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2014-09-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved Humira's supplemental application submitted by Cordavis Limited. The approval acts as a supplemental approval to the existing H…

• FDA approval · 2014-09-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) to add Cordavis Limited as a supplier. This action supports continued av…

• FDA approval · 2014-07-30
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for CANASA (mesalamine) from Allergan, Inc.

• FDA approval · 2014-05-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited under BLA125057.

• FDA approval · 2014-05-20
  FDA Approved: ENTYVIO — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved Entyvio (vedolizumab) in its original application for treatment of moderate-to-severe Crohn's disease and ulcerative colitis.

• EMA approval · 2014-03-21
  European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease

  The European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease.

• FDA approval · 2014-03-14
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc. The action likely updates the …

• FDA approval · 2014-01-02
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for CANASA (mesalamine) filed by Allergan, Inc.

• FDA approval · 2013-10-25
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Mesalamine from Teva Pharmaceuticals USA, Inc., resulting in changes to its labeling per the…

• FDA approval · 2013-08-28
  FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

• FDA approval · 2013-07-23
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, Inc. The action involves an update to …

• FDA approval · 2013-05-15
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Simponi (golimumab) from Janssen Biotech, Inc., expanding the labeling for the product.

• FDA approval · 2013-05-14
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for mercaptopurine from Mylan Pharmaceuticals Inc., authorizing a generic version under an appro…

• FDA approval · 2013-05-03
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for CANASA (mesalamine), indicating a regulatory action to update or expand the product…

• FDA approval · 2013-04-29
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab from Janssen Biotech, expanding its labeling and indications.

• FDA approval · 2013-04-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2013-01-25
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc.

• FDA approval · 2013-01-14
  FDA Approved: BUDESONIDE — Original Application (Oceanside Pharmaceuticals)

  FDA approved the original application for budesonide from Oceanside Pharmaceuticals.