Ankylosing Spondylitis

• 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 · 2014-11-28
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for a diclofenac sodium product manufactured by Aurobindo Pharma Limited.

• FDA approval · 2014-11-02
  FDA Approved: NAPROXEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Naproxen by Amneal Pharmaceuticals of New York LLC (generic Naproxen).

• FDA approval · 2014-10-29
  FDA Approved: CELECOXIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic version of celecoxib (Celecoxib) under an original ANDA.

• FDA approval · 2014-10-16
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  FDA approved a supplemental application for Indocin (indomethacin) submitted by Zyla Life Sciences US LLC.

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• 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 · 2014-09-03
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Diclofenac sodium and misoprostol from Mylan Pharmaceuticals, typically reflecting labeling upda…

• 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 · 2013-10-28
  FDA Approved: DICLOFENAC SODIUM — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved Amneal's Original Application for Diclofenac Sodium Tablets, a generic NSAID indicated for relief of pain and inflammation in s…

• FDA approval · 2013-06-12
  FDA Approved: MELOXICAM — Supplemental Application (Carlsbad Technology, Inc.)

  FDA approved a supplemental application for Meloxicam (Carlsbad Technology, Inc.), a generic NSAID, under ANDA077918. The approval concerns …

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

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

• FDA approval · 2013-04-18
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approves a supplemental application for Aleve GelCaps to expand labeling for naproxen sodium, broadening indications for pain relief.

• FDA approval · 2013-02-07
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new dosage form for the Aleve product line, expanding th…

• FDA approval · 2012-12-10
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

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

• FDA approval · 2012-12-04
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

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

• 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 · 2012-09-28
  FDA Approved: INDOMETHACIN — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' indomethacin as an original ANDA (generic) application, making Indomethacin available as a generic …

• FDA approval · 2012-06-13
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., updating the product's regulatory approval.

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

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

• FDA approval · 2012-03-15
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps containing naproxen sodium, expanding the approval to include a new dosage form…

• 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.