Rheumatoid Arthritis

• 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 · 2013-03-07
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental NDA for diclofenac sodium and misoprostol from Mylan Pharmaceuticals.

• 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 · 2013-02-07
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Etodolac from Apotex Corp. under an ANDA.

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• FDA approval · 2013-02-05
  FDA Approved: METHOTREXATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA's supplemental application for methotrexate, enabling the marketing of a generic methotrexate product…

• 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 · 2012-12-10
  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 · 2012-11-06
  FDA Approved: XELJANZ — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved XELJANZ (tofacitinib) from Pfizer under its original application for rheumatoid arthritis, marking the initial approval of the …

• FDA approval · 2012-10-03
  FDA Approved: SULFASALAZINE — Supplemental Application (Sunrise Pharmaceutical, Inc.)

  The FDA approved a supplemental application for sulfasalazine from Sunrise Pharmaceutical, Inc., marking an approval action for this generic…

• FDA approval · 2012-10-01
  FDA Approved: OXAPROZIN — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for Oxaprozin filed by Chartwell RX, LLC., updating an existing approved generic oxaprozin product.

• 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 · 2012-08-13
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for Actemra (tocilizumab) submitted by Genentech, broadening its labeling.

• FDA approval · 2012-07-09
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Original Application (BluePoint Laboratories)

  FDA approved a diclofenac sodium and misoprostol product under an Original Application for BluePoint Laboratories, signaling a generic clear…

• 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 · 2012-03-05
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

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

• 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.

• FDA approval · 2011-11-21
  FDA Approved: LEFLUNOMIDE — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic Leflunomide product from Alembic Pharmaceuticals Limited under an original ANDA for the treatment of rheumatoid arthr…

• 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…