Gouty Arthritis

• EMA approval · 2025-07-14
  EMA Authorised: Febuxostat Viatris (previously Febuxostat Mylan) (febuxostat) — Viatris Limited

  The EMA authorised Febuxostat Viatris (febuxostat) by Viatris Limited for hyperuricemia and gout, including gouty arthritis indications.

• FDA approval · 2025-02-24
  FDA Approved: INDOMETHACIN — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal Pharmaceuticals NY LLC's original application for Indomethacin, authorizing a generic version of the NSAID with the same…

• 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 · 2021-04-28
  FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)

  The FDA has approved a supplemental application for INDOCIN (indomethacin) by Zyla Life Sciences US LLC.

• FDA approval · 2021-04-28
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for Indomethacin, approving a generic Indomethacin product.

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• FDA approval · 2010-03-17
  FDA Approved: INDOMETHACIN — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved an original NDA for indomethacin from Fresenius Kabi USA, LLC. The approval covers indications for inflammatory and musculo…