Ankylosing Spondylitis

• FDA approval · 2011-11-08
  FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for a generic naproxen product. Naproxen is a nonsteroidal anti-inflammator…

• FDA approval · 2011-10-31
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Meloxicam from Aurobindo Pharma Limited. This approval updates the approved product under th…

• FDA approval · 2011-09-19
  FDA Approved: NAPROXEN — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Naproxen under Original Application, making a generic naproxen product available. It is used to relieve pain a…

• FDA approval · 2011-09-07
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Cimzia (certolizumab pegol) submitted by UCB, Inc. This action approves the changes described in…

• FDA approval · 2011-09-07
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

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

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• FDA approval · 2011-08-24
  FDA Approved: NAPROXEN — Original Application (Exelan Pharmaceuticals, Inc.)

  The FDA approved Exelan Pharmaceuticals' original ANDA for Naproxen (generic naproxen). This confirms a generic naproxen product for arthrit…

• FDA approval · 2011-02-17
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for infliximab from Janssen Biotech, Inc., signaling a labeling update or expansion of its appro…

• FDA approval · 2010-12-28
  FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved Janssen Biotech, Inc.'s supplemental application for infliximab. The approval updates the product's labeling and indications as…

• FDA approval · 2010-12-01
  FDA Approved: DICLOFENAC SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original ANDA for Diclofenac Sodium (generic diclofenac) from Rising Pharma Holdings, Inc., providing a generic diclofenac …

• FDA approval · 2010-10-26
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Zydus Pharmaceuticals USA Inc., resulting in changes to the labeling.…

• FDA approval · 2010-08-12
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  The FDA approved a supplemental application for Naproxen Sodium submitted by Bionpharma Inc.

• FDA approval · 2010-07-29
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

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

• FDA approval · 2010-07-06
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for diclofenac sodium from Edenbridge Pharmaceuticals LLC under the ANDA program. This action consti…

• FDA approval · 2010-06-03
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2010-04-26
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

  FDA approved a supplemental application for ZYBIC (meloxicam) submitted by Redmont Pharmaceuticals, LLC.

• FDA approval · 2010-03-19
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited. This action authorizes changes to the approved …

• FDA approval · 2010-03-17
  FDA Approved: INDOMETHACIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an original NDA for indomethacin from Fresenius Kabi USA, LLC. The approval covers indications for inflammatory and musculo…

• FDA approval · 2009-09-24
  FDA Approved: MELOXICAM — Supplemental Application (Carlsbad Technology, Inc.)

  The FDA approved a supplemental application for Meloxicam from Carlsbad Technology, Inc., indicating the supplemental action for the generic…

• FDA approval · 2009-05-13
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2009-04-24
  FDA Approved: SIMPONI — Original Application (Janssen Biotech, Inc.)

  FDA approved the original Biologics License Application for Simponi (golimumab) from Janssen Biotech, Inc.

• FDA approval · 2009-03-06
  FDA Approved: INDOMETHACIN — Original Application (KVK-Tech, Inc.)

  FDA approved an original application for Indomethacin by KVK-Tech, Inc., establishing a generic version of indomethacin. The approval signif…

• FDA approval · 2008-07-25
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  The FDA has approved a supplemental application for naproxen filed by Zameer Pharmaceuticals LLC.

• FDA approval · 2008-02-05
  FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for sulindac from Actavis Pharma, Inc. This action updates the labeling for the drug under the appro…

• FDA approval · 2008-01-14
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Celebrex (celecoxib) submitted by Viatris Specialty LLC to update the product labeling under NDA…

• FDA approval · 2007-11-07
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…