Rheumatoid Arthritis

• FDA approval · 2024-05-14
  FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approves a supplemental application for XELJANZ XR (tofacitinib) from Pfizer, introducing the extended-release formulation. Submission s…

• FDA approval · 2024-05-01
  FDA Approved: ETODOLAC — Original Application (Ipca Laboratories Limited)

  FDA approved Etodolac from Ipca Laboratories Limited as a generic product (Original Application under ANDA 204729). It is indicated for reli…

• FDA approval · 2024-04-30
  FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…

• FDA approval · 2024-04-26
  FDA Approved: RINVOQ — Original Application (AbbVie Inc.)

  The FDA approved Rinvoq (upadacitinib) from AbbVie under an Original Application NDA, granting the drug its initial US marketing authorizati…

• FDA approval · 2024-03-29
  FDA Approved: DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL — Supplemental Application (Micro Labs Limited)

  FDA approved a supplemental application for the generic Diclofenac Sodium/Misoprostol product from Micro Labs Limited, authorizing its marke…

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• FDA approval · 2024-03-21
  FDA Approved: DICLOFENAC SODIUM MISOPROSTOL — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Diclofenac Sodium with Misoprostol (Nivagen Pharmaceuticals, Inc.). The labeling supports use fo…

• FDA approval · 2024-03-15
  FDA Approved: ETODOLAC — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Etodolac from Amneal Pharmaceuticals NY LLC. The action adds to the existing approval for this N…

• FDA approval · 2024-03-05
  FDA Approved: TYENNE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved TYENNE (tocilizumab-AAZG) from Fresenius Kabi USA, LLC under an Original Application.

• FDA approval · 2024-02-22
  FDA Approved: ZYMFENTRA — Supplemental Application (CELLTRION USA Inc.)

  The FDA approved a supplemental application for ZYMFENTRA (infliximab-dyyb) submitted by Celltrion USA Inc.

• FDA approval · 2024-02-20
  FDA Approved: TERIFLUNOMIDE — Supplemental Application (Teva Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Teva's teriflunomide (generic) under ANDA209700.

• FDA approval · 2024-01-24
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for hydroxychloroquine sulfate manufactured by Ipca Laboratories Limited. The approval updates the p…

• FDA approval · 2023-12-28
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved AiPing Pharmaceutical, Inc.'s supplemental application for MELOXICAM (meloxicam).

• FDA approval · 2023-12-26
  FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Renflexis (infliximab) submitted by Organon LLC.

• FDA approval · 2023-12-15
  FDA Approved: HULIO — Supplemental Application (Biocon Biologics Inc)

  The FDA approved a supplemental application for HULIO, Biocon Biologics' biosimilar adalimumab (adalimumab-fkJP).

• FDA approval · 2023-12-14
  FDA Approved: CYCLOSPORINE — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approves Teva Pharmaceuticals' generic cyclosporine under an original application (ANDA 203880), expanding access to this immunosuppress…

• FDA approval · 2023-12-05
  FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)

  FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…

• FDA approval · 2023-11-30
  FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)

  The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…

• FDA approval · 2023-11-29
  FDA Approved: HYDROXYCHLOROQUINE SULFATE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for HYDROXYCHLOROQUINE SULFATE from Dr. Reddy's Laboratories Inc.

• FDA approval · 2023-11-08
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for CIMZIA (certolizumab pegol) from UCB, Inc., updating its labeling and/or indications.

• FDA approval · 2023-11-03
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…

• FDA approval · 2023-10-20
  FDA Approved: COXANTO — Original Application (SOLA Pharmaceuticals, LLC)

  The FDA approved COXANTO (oxaprozin) from SOLA Pharmaceuticals in its original application, enabling its use for pain and inflammation assoc…

• FDA approval · 2023-10-20
  FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)

  FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…

• FDA approval · 2023-10-18
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  The FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• FDA approval · 2023-10-11
  FDA Approved: NAPROXEN AND ESOMEPRAZOLE MAGNESIUM — Original Application (ScieGen Pharmaceuticals, Inc)

  FDA approved Naproxen and Esomeprazole Magnesium (ScieGen Pharmaceuticals) under Original Application. The combination is indicated for reli…

• 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…