Ankylosing Spondylitis

• FDA approval · 2007-10-25
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved a supplemental application for MELOXICAM from AiPing Pharmaceutical, Inc., resulting in the availability of a generic meloxicam…

• FDA approval · 2007-09-25
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…

• FDA approval · 2007-08-24
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the Diclofenac sodium and misoprostol combination product from Mylan Pharmaceuticals.

• 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 · 2007-07-26
  FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…

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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 · 2007-04-19
  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 · 2006-12-20
  FDA Approved: MELOXICAM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original ANDA for Meloxicam, manufactured by Unichem Pharmaceuticals (USA), Inc., introducing a generic version of the NSAI…

• FDA approval · 2006-12-19
  FDA Approved: DG HEALTH NAPROXEN SODIUM — Supplemental Application (Dolgencorp Inc)

  FDA approved a supplemental application for DG Health Naproxen Sodium (naproxen sodium) by Dolgencorp Inc. The action approves the generic p…

• 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…