Crohn Disease

• FDA approval · 2015-11-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) filed by Cordavis Limited, indicating regulatory action on a Humira supp…

• FDA approval · 2015-11-20
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide filed by Rite Aid Corporation (ANDA078949), confirming an updated approval for this g…

• 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.

• 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…

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• 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 · 2014-03-04
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab from Janssen Biotech, Inc., leading to changes in its labeling/approved use.

• 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 · 2013-05-24
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved a Biogen supplemental application for TYSABRI (Natalizumab). The action indicates a modification/expansion of the product l…

• 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 · 2013-04-29
  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.

• FDA approval · 2012-12-12
  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 · 2012-09-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2012-08-01
  FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Mercaptopurine from Hikma Pharmaceuticals USA Inc., supporting the generic product under AND…

• FDA approval · 2012-05-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2012-05-02
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., resulting in a labeling change/addition.

• FDA approval · 2012-04-17
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc.

• FDA approval · 2012-01-20
  FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)

  The FDA approved Biogen Inc.'s supplemental application for TYSABRI (natalizumab). This action updates the product's labeling per the submis…

• FDA approval · 2011-12-26
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2011-12-13
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.