Rheumatoid Arthritis

• FDA approval · 2015-04-29
  FDA Approved: ARAVA — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for ARAVA (leflunomide) submitted by sanofi-aventis U.S. LLC.

• FDA approval · 2015-03-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept), expanding its label with additional indications. The submission status indi…

• FDA approval · 2015-01-20
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for hydroxychloroquine sulfate submitted by Aurobindo Pharma Limited.

• 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.

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• FDA approval · 2014-11-14
  FDA Approved: ARAVA — Supplemental Application (sanofi-aventis U.S. LLC)

  The FDA document concerns a supplemental application for ARAVA (leflunomide) by Sanofi-Aventis U.S. LLC, indicating a supplemental approval …

• FDA approval · 2014-11-13
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ACTEMRA (tocilizumab) submitted by Genentech, Inc. This action involves an approved product …

• 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 · 2014-10-25
  FDA Approved: CYCLOPHOSPHAMIDE — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for Civica, Inc. to market a generic cyclophosphamide product.

• 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.

• FDA approval · 2014-10-08
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  FDA approved a supplemental application for OTREXUP (methotrexate) submitted by Antares Pharma, Inc.

• 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 · 2014-01-23
  FDA Approved: ETODOLAC — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves the original ANDA for etodolac (generic) manufactured by Zydus Pharmaceuticals USA Inc.

• FDA approval · 2014-01-16
  FDA Approved: CYCLOSPORINE — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for cyclosporine from Apotex Corp, authorizing changes under the generic product's regulatory fi…

• 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 · 2013-10-21
  FDA Approved: ACTEMRA — Original Application (Genentech, Inc.)

  FDA approved Actemra (tocilizumab) under an Original Biologics License Application from Genentech. The approval was for the treatment of rhe…

• FDA approval · 2013-10-11
  FDA Approved: OTREXUP — Original Application (Antares Pharma, Inc.)

  FDA approved OTREXUP, a subcutaneous methotrexate injection from Antares Pharma, under an original NDA for autoimmune conditions including r…

• FDA approval · 2013-06-13
  FDA Approved: MELOXICAM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for meloxicam from Unichem Pharmaceuticals (USA), Inc., enabling a generic version of the NSAID for …

• 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 · 2013-05-14
  FDA Approved: RIDAURA — Supplemental Application (Sebela Pharmaceuticals Inc.)

  FDA approved a supplemental application for RIDAURA (auranofin) by Sebela Pharmaceuticals Inc., extending regulatory authorization for the e…