Rheumatoid Arthritis

• FDA approval · 2023-09-14
  FDA Approved: SOVUNA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for SOVUNA (hydroxychloroquine sulfate) submitted by ANI Pharmaceuticals, under NDA 214581.

• FDA approval · 2023-09-07
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Indomethacin submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2023-08-31
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for tolmetin sodium from Atland Pharmaceuticals, LLC. This action approves changes under an appr…

• FDA approval · 2023-08-24
  FDA Approved: SULFASALAZINE — Supplemental Application (Chartwell RX, LLC.)

  FDA approved a supplemental application for the generic drug sulfasalazine submitted by Chartwell RX, LLC.

• FDA approval · 2023-08-17
  FDA Approved: OXAPROZIN — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Oxaprozin submitted by Dr. Reddy's Laboratories Limited.

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• FDA approval · 2023-07-19
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar of adalimumab from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-06-30
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA approved a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC.

• FDA approval · 2023-06-14
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ABRILADA (adalimumab-afzb) submitted by Pfizer Laboratories Div Pfizer Inc to update the labelin…

• FDA approval · 2023-06-07
  FDA Approved: MELOXICAM — Original Application (XLCare Pharmaceuticals, Inc.)

  The FDA approved the original application for MELOXICAM (meloxicam), a generic version manufactured by XLCare Pharmaceuticals, Inc., under A…

• FDA approval · 2023-05-23
  FDA Approved: ADALIMUMAB — Original Application (CELLTRION USA, Inc.)

  FDA approved ADALIMUMAB-AATY from CELLTRION USA, Inc. as a biosimilar to adalimumab under an Original Application for the same indications a…

• FDA approval · 2023-05-18
  FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar to adalimumab, from QUALLENT PHARMACEUTICALS HEALTH LLC.

• FDA approval · 2023-05-05
  FDA Approved: IBUPROFEN — Supplemental Application (Winco Foods, LLC)

  The FDA approved a supplemental application for a generic ibuprofen product developed by Winco Foods, LLC.

• FDA approval · 2023-05-05
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate from Sun Pharmaceutical Industries, Inc., updating the approval for t…

• FDA approval · 2023-04-14
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for adalimumab-adaz, a biosimilar to adalimumab, confirming its regulatory approval for use.

• FDA approval · 2023-03-31
  FDA Approved: YUSIMRY — Supplemental Application (Coherus BioSciences Inc)

  FDA approved a supplemental Biologics License Application for YUSIMRY (adalimumab-aqvh) by Coherus BioSciences, authorizing the biosimilar p…

• FDA approval · 2023-03-30
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxychloroquine sulfate filed by Teva Pharmaceuticals USA, Inc., marking an approved change u…

• FDA approval · 2023-02-03
  FDA Approved: PIROXICAM — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for piroxicam from Strides Pharma Science Limited. This action completes another regulatory submissi…

• FDA approval · 2022-12-22
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for the fixed-dose combination diclofenac sodium and misoprostol from Mylan Pharmaceuticals Inc. The…

• FDA approval · 2022-12-13
  FDA Approved: IDACIO — Original Application (Fresenius Kabi USA, LLC)

  FDA approved IDACIO (adalimumab-afcf) from Fresenius Kabi USA, LLC as a biosimilar to adalimumab (Humira) under an original Biologics Licens…

• FDA approval · 2022-11-29
  FDA Approved: JYLAMVO — Original Application (SHORLA ONCOLOGY INC.)

  FDA approved JYLAMVO (methotrexate) under an Original Application from SHORLA ONCOLOGY INC.

• FDA approval · 2022-11-16
  FDA Approved: AZULFIDINE EN-TABS — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Azulfidine En-Tabs (sulfasalazine) filed by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2022-11-15
  FDA Approved: CAREONE IBUPROFEN — Supplemental Application (American Sales Company)

  The FDA approved a supplemental application for CAREONE IBUPROFEN (ibuprofen) filed by American Sales Company under ANDA077349.

• FDA approval · 2022-11-09
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for Daypro (oxaprozin) from Pfizer Laboratories Div Pfizer Inc, indicating an approved update re…

• FDA approval · 2022-10-28
  FDA Approved: NAPROXEN SODIUM — Original Application (Camber Consumer Care Inc)

  FDA approved Naproxen Sodium generic from Camber Consumer Care Inc under an Original Application (ANDA211065).

• FDA approval · 2022-10-06
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s Naproxen and Esomeprazole Magnesium as an Original Application (ANDA213699), providing a generic versi…