Rheumatoid Arthritis

• FDA approval · 2017-01-11
  FDA Approved: OTREXUP — Supplemental Application (Antares Pharma, Inc.)

  The FDA approved a supplemental application for OTREXUP (methotrexate) filed by Antares Pharma, Inc. This update expands the regulatory auth…

• FDA approval · 2016-12-20
  FDA Approved: TREXALL — Supplemental Application (Teva Women's Health, Inc.)

  FDA approved a supplemental application for TREXALL (methotrexate) from Teva Women's Health, Inc.

• EMA approval · 2016-12-16
  New oral treatment for rheumatoid arthritis

  The EMA announces a new oral treatment for rheumatoid arthritis, indicating regulatory approval and availability for patients.

• FDA approval · 2016-11-25
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's diclofenac sodium and misoprostol as an original ANDA, enabling a generic version of the diclo…

• FDA approval · 2016-10-18
  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.

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• FDA approval · 2016-09-16
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for celecoxib (generic) under ANDA204197.

• FDA approval · 2016-09-14
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for CELECOXIB from Aurobindo Pharma Limited (ANDA206827). This notice confirms the supplemental appr…

• FDA approval · 2016-09-02
  FDA Approved: DICLOFENAC SODIUM — Original Application (SOLA Pharmaceuticals, LLC)

  FDA approved SOLA Pharmaceuticals' diclofenac sodium tablet as an original generic, indicated for relief of pain and inflammation in conditi…

• FDA approval · 2016-09-01
  FDA Approved: ZYBIC — Supplemental Application (Redmont Pharmaceuticals, LLC)

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

• FDA approval · 2016-08-15
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM from Zydus Pharmaceuticals USA Inc., granting approval to market generic meloxicam in …

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Tolmetin sodium submitted by Atland Pharmaceuticals, LLC under ANDA073393.

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for tolmetin sodium submitted by Atland Pharmaceuticals, LLC.

• FDA approval · 2016-05-09
  FDA Approved: ETODOLAC — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for etodolac from ANI Pharmaceuticals, Inc., granting regulatory approval for a change to the produc…

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for nabumetone submitted by Chartwell RX, LLC.

• FDA approval · 2016-05-09
  FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for sulindac from Actavis Pharma, Inc.

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited.

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for Nabumetone from ScieGen Pharmaceuticals Inc. The action updates the product's labeling based on …

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's supplemental application for INDOMETHACIN, marking an approved modification to the product under an ANDA.

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Indomethacin, resulting in updated labeling for the product.

• FDA approval · 2016-05-09
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for etodolac submitted by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2016-05-09
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen submitted by Zameer Pharmaceuticals LLC.

• FDA approval · 2016-05-09
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for DAYPRO (oxaprozin) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for diclofenac sodium and misoprostol from Mylan Pharmaceuticals Inc., marking an approved chang…

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Nabumetone from Exelan Pharmaceuticals Inc. This action typically updates labeling or adds a…