Ankylosing Spondylitis

• FDA approval · 2024-12-19
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA supplemental approval for Aurobindo Pharma Limited's generic celecoxib.

• FDA approval · 2024-12-18
  FDA Approved: IDACIO — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for IDACIO (adalimumab-aacf) from Fresenius Kabi USA, LLC.

• FDA approval · 2024-11-21
  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., updating the product's la…

• FDA approval · 2024-11-21
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for Tolmetin Sodium (generic tolmetin) from Atland Pharmaceuticals, LLC.

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for MELOXICAM from Zydus Pharmaceuticals USA Inc., as part of an ANDA, indicating approval of an…

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• FDA approval · 2024-11-21
  FDA Approved: INDOMETHACIN — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for indomethacin submitted by Chartwell RX, LLC. This action represents an approved supplement t…

• FDA approval · 2024-11-21
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves a supplemental application for Indomethacin from Amneal Pharmaceuticals LLC (ANDA 091549), authorizing a supplemental change to…

• FDA approval · 2024-11-21
  FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Celebrex (celecoxib) filed by Viatris Specialty LLC. The approval covers changes requested i…

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)

  FDA approved a supplemental application for meloxicam from AiPing Pharmaceutical, Inc. The approval pertained to updating the labeling under…

• FDA approval · 2024-11-21
  FDA Approved: MELOXICAM — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for meloxicam, confirming regulatory clearance for the product.

• FDA approval · 2024-09-27
  FDA Approved: CELECOXIB — Supplemental Application (Actavis Pharma, Inc.)

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

• FDA approval · 2024-08-26
  FDA Approved: ADALIMUMAB-RYVK — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for ADALIMUMAB-RYVK, a biosimilar to adalimumab, submitted by Quallent Pharmaceuticals Health LL…

• 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…

• 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 · 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 · 2023-11-30
  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 · 2023-11-20
  FDA Tentative Approval: TALTZ — Supplemental Application (Eli Lilly and Company)

  The FDA issued tentative approval for a supplemental application for TALTZ (ixekizumab) by Eli Lilly, indicating the submission is approvabl…

• 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: 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…