Rheumatoid Arthritis

• FDA approval · 2018-04-30
  FDA Approved: CELECOXIB — Original Application (Micro Labs Limited)

  FDA approved the original generic application for celecoxib from Micro Labs Limited, providing a generic celecoxib option aligned with the r…

• FDA approval · 2018-03-27
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental NDA for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC. The approval adds a gel-cap dosage form for thi…

• FDA approval · 2018-03-20
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

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

• FDA approval · 2018-03-15
  FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)

  FDA approved a supplemental application for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited.

• FDA approval · 2018-03-15
  FDA Approved: METHOTREXATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Methotrexate submitted by Hospira, Inc.

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• FDA approval · 2018-02-09
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

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

• FDA approval · 2018-01-23
  FDA Approved: CELECOXIB — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' generic celecoxib as an Original Application (ANDA210071), enabling market entry for this COX-2 in…

• FDA approval · 2017-12-29
  FDA Approved: PIROXICAM — Original Application (Micro Labs Limited)

  FDA approved Micro Labs Limited's Original Application (ANDA) for Piroxicam.

• FDA approval · 2017-12-21
  FDA Approved: DOLEX FLEX — Original Application (Pharmadel LLC)

  FDA approved DOLEX FLEX (ibuprofen) through Pharmadel LLC's original ANDA.

• FDA approval · 2017-12-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for XELJANZ XR (tofacitinib) filed by Pfizer Laboratories Div Pfizer Inc, enabling the extended-rele…

• FDA approval · 2017-08-22
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application for ALEVE GELCAPS (naproxen sodium) by Bayer HealthCare LLC., expanding the product through a supple…

• FDA approval · 2017-06-30
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for ORENCIA (abatacept) submitted by E.R. Squibb & Sons, L.L.C. This action updates the product labe…

• FDA approval · 2017-06-22
  FDA Approved: RITUXAN HYCELA — Original Application (Genentech, Inc.)

  FDA approved RITUXAN HYCELA (rituximab and hyaluronidase) under an Original Application by Genentech. The subcutaneous formulation provides …

• FDA approval · 2017-06-22
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for Simponi (golimumab) submitted by Janssen Biotech, Inc.

• FDA approval · 2017-06-22
  FDA Approved: INDOMETHACIN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's Indomethacin generic under an Original Application; this entry records the approval status and product details.

• FDA approval · 2017-06-16
  FDA Approved: DIFLUNISAL — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a generic diflunisal product (DIFLUNISAL) under ANDA 203547 for Zydus Pharmaceuticals USA Inc. It is indicated for relief of mi…

• FDA approval · 2017-05-22
  FDA Approved: KEVZARA — Original Application (Sanofi-Aventis U.S. LLC)

  This FDA entry documents the original approval of Kevzara (sarilumab) by Sanofi-Aventis U.S. LLC. It pertains to the initial regulatory auth…

• FDA approval · 2017-05-22
  FDA Approved: ACTEMRA — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for ACTEMRA (tocilizumab) submitted by Genentech, Inc. The supplementary filing status is AP (approv…

• FDA approval · 2017-05-04
  FDA Approved: OXAPROZIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Oxaprozin generic from Amneal Pharmaceuticals NY LLC for the treatment of rheumatoid arthritis and osteoarthritis.

• FDA approval · 2017-04-21
  FDA Approved: RENFLEXIS — Original Application (Organon LLC)

  The FDA approved RENFLEXIS (infliximab) from Organon LLC based on an original application, making it a biosimilar to Remicade. The approval …

• FDA approval · 2017-04-13
  FDA Approved: PIROXICAM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s Original Application for piroxicam, authorizing a generic version of the NSAID piroxicam.

• FDA approval · 2017-03-10
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

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

• FDA approval · 2017-03-07
  FDA Approved: METHOTREXATE — Supplemental Application (Fresenius Kabi USA, LLC)

  The FDA approved a supplemental application for METHOTREXATE SODIUM from Fresenius Kabi USA, LLC.

• FDA approval · 2017-01-27
  FDA Approved: PLAQUENIL — Supplemental Application (Advanz Pharma (US) Corp.)

  The FDA approved a supplemental application for Plaquenil (hydroxychloroquine sulfate) from Advanz Pharma (US) Corp.

• FDA approval · 2017-01-23
  FDA Approved: NAPROXEN — Original Application (Amerisource Bergen)

  FDA approves AmerisourceBergen's original application for naproxen sodium tablets, a generic naproxen product.