Ankylosing Spondylitis

• FDA approval · 2023-09-21
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…

• 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 · 2023-07-24
  FDA Approved: COSENTYX — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Cosentyx (secukinumab) submitted by Novartis Pharmaceuticals Corporation.

• 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.

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• 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 · 2023-04-14
  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 · 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 · 2022-10-28
  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…

• FDA approval · 2022-09-15
  FDA Approved: CELECOXIB — Supplemental Application (Westminster Pharmaceuticals, LLC)

  The FDA approved a supplemental application for a generic celecoxib product from Westminster Pharmaceuticals, expanding access under ANDA210…

• FDA approval · 2022-09-06
  FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)

  The FDA approved a supplemental application for naproxen sodium sponsored by CVS.

• FDA approval · 2022-07-18
  FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)

  The FDA approved Sandoz's supplemental application for the adalimumab biosimilar ADALIMUMAB-ADAZ. The approval covers multiple inflammatory …

• FDA approval · 2022-06-17
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) from Immunex Corporation, resulting in labeling changes for the product.…

• FDA approval · 2022-06-07
  FDA Approved: NAPROXEN — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber's naproxen generic original application for Naproxen. This generic NSAID is approved for relief of pain and inflammation…

• FDA approval · 2022-05-06
  FDA Approved: DICLOFENAC SODIUM — Original Application (Apotex Corp.)

  FDA approved Apotex Corp's original application for diclofenac sodium tablets, a generic NSAID. This approval enables Apotex to market a gen…

• FDA approval · 2022-03-11
  FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)

  FDA approved a supplemental application for naproxen sodium granules from Granules India Ltd, resulting in an approved supplemental request …

• FDA approval · 2022-03-09
  FDA Approved: CELECOXIB — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for Celecoxib from Micro Labs Limited under an ANDA.

• FDA approval · 2022-02-08
  FDA Approved: PIROXICAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Piroxicam submitted by Teva Pharmaceuticals USA, Inc.

• FDA approval · 2022-01-11
  FDA Approved: CELECOXIB — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for Celecoxib submitted by NIVAGEN Pharmaceuticals, Inc., for a generic Celecoxib product.

• FDA approval · 2022-01-07
  FDA Approved: MELOXICAM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for MELOXICAM (meloxicam) from Aurobindo Pharma Limited.

• FDA approval · 2022-01-05
  FDA Approved: CELECOXIB — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic celecoxib product (Celecoxib) under ANDA 202240.

• FDA approval · 2021-12-17
  FDA Approved: YUSIMRY — Original Application (Coherus BioSciences Inc)

  FDA approved YUSIMRY (adalimumab-aqvh) from Coherus BioSciences in an original biologics license application, likely as a biosimilar to adal…