Ulcerative Colitis

• FDA approval · 2007-12-28
  FDA Approved: BALSALAZIDE DISODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved an original application for balsalazide disodium, a generic oral anti-inflammatory for ulcerative colitis, for Hikma Pharmaceut…

• FDA approval · 2007-12-28
  FDA Approved: BALSALAZIDE DISODIUM — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s generic balsalazide disodium (ANDA) as a generic version of balsalazide for the treatment of ulcerative coli…

• FDA approval · 2007-07-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2007-07-10
  FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2007-06-26
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

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

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• FDA approval · 2007-06-12
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for infliximab (Remicade) submitted by Janssen Biotech, Inc. The approval updates the labeling to re…

• FDA approval · 2007-05-22
  FDA Approved: MESALAMINE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for MESALAMINE from Padagis Israel Pharmaceuticals Ltd under an ANDA. The approval signifies a suppl…

• FDA approval · 2007-04-19
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab (Remicade) from Janssen Biotech, Inc., updating the product labeling per the supp…

• FDA approval · 2007-03-16
  FDA Approved: MESALAMINE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  The FDA approved a supplemental application for mesalamine from Padagis Israel Pharmaceuticals Ltd. This action updates regulatory approval …

• FDA approval · 2007-01-16
  FDA Approved: LIALDA — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approval of LIALDA (mesalamine) under Takeda Pharmaceuticals America's original NDA for the treatment of ulcerative colitis.

• FDA approval · 2006-12-08
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for infliximab submitted by Janssen Biotech, Inc.

• FDA approval · 2006-09-26
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., updating the drug's labeling.

• FDA approval · 2006-07-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited, likely to authorize a new contract manufactur…

• FDA approval · 2006-06-27
  FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for PENTASA (mesalamine) from Takeda Pharmaceuticals America, Inc., granting updated labeling an…

• FDA approval · 2006-06-08
  FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)

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