Hyperuricemia

• EMA approval · 2026-08-19
  EMA Authorised: Febuxostat Viatris (previously Febuxostat Mylan) (febuxostat) — Viatris Limited

  European Medicines Agency authorised Febuxostat Viatris for hyperuricemia and gout-related indications.

• 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 · 2025-06-13
  FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for Allopurinol from Zydus Lifesciences Limited.

• FDA approval · 2025-04-14
  FDA Approved: ALLOPURINOL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Allopurinol from Aurobindo Pharma Limited, authorizing a generic version of allopurinol.

• EMA approval · 2025-03-27
  EMA Authorised: Febuxostat Krka (febuxostat) — Krka, d.d., Novo mesto

  The EU authorities authorised Febuxostat Krka for the treatment of hyperuricemia and gout.

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• FDA approval · 2025-02-11
  FDA Approved: ALLOPURINOL — Supplemental Application (Accord Healthcare Inc.)

  FDA approved a supplemental application for Allopurinol from Accord Healthcare Inc., indicating an additional approval for the generic produ…

• FDA approval · 2024-08-30
  FDA Approved: ALLOPURINOL — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Allopurinol from Camber Pharmaceuticals, Inc. under the ANDA program. This action constitutes a …

• EMA approval · 2024-08-12
  EMA Authorised: Fasturtec (rasburicase) — Sanofi Winthrop Industrie

  The EMA authorised Fasturtec (rasburicase) by Sanofi Winthrop Industrie for hyperuricemia.

• FDA approval · 2024-07-22
  FDA Approved: FEBUXOSTAT — Supplemental Application (HEC Pharm USA Inc.)

  FDA approved a supplemental application for FEBUXOSTAT submitted by HEC Pharm USA Inc. The action supplements the approved Febuxostat produc…

• FDA approval · 2024-04-03
  FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Allopurinol from Actavis Pharma, Inc., authorizing changes to the product’s labeling.

• FDA approval · 2024-02-16
  FDA Approved: ALLOPURINOL — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Allopurinol submitted by Par Health USA, LLC.

• FDA approval · 2024-02-05
  FDA Approved: ALLOPURINOL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for allopurinol from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals) under ANDA204467. The app…

• FDA approval · 2024-02-05
  FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for ALLOPURINOL (Allopurinol) submitted by Zydus Lifesciences Limited, authorizing changes to the ap…

• FDA approval · 2024-01-29
  FDA Approved: ALLOPURINOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Allopurinol from Sun Pharmaceutical Industries, Inc., indicating an approved update to the drug'…

• FDA approval · 2023-11-29
  FDA Approved: FEBUXOSTAT — Supplemental Application (Tris Pharma Inc)

  The FDA approved a supplemental application for febuxostat from Tris Pharma Inc, enabling a generic version of the gout medication.

• FDA approval · 2023-11-28
  FDA Approved: FEBUXOSTAT — Supplemental Application (Solco Healthcare US LLC)

  FDA approved a supplemental application for febuxostat from Solco Healthcare US LLC, authorizing changes to the approved product.

• FDA approval · 2023-11-20
  FDA Approved: PROBENECID — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Probenecid filed by Rising Pharma Holdings, Inc., typically related to changes in labeling o…

• FDA approval · 2023-11-20
  FDA Approved: PROBENECID — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved Rising Pharma Holdings' original application for a generic probenecid product. Probenecid is a uricosuric agent used to tre…

• FDA approval · 2023-10-25
  FDA Approved: FEBUXOSTAT — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for febuxostat submitted by Aurobindo Pharma Limited, authorizing marketing of a generic febuxostat pr…

• FDA approval · 2023-09-28
  FDA Approved: FEBUXOSTAT — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved an original Abbreviated New Drug Application (ANDA) for febuxostat tablets 40 mg and 80 mg by Macleods Pharmaceuticals Limited.…

• FDA approval · 2023-09-19
  FDA Approved: FEBUXOSTAT — Supplemental Application (Zydus Lifesciences Limited)

  FDA approved a supplemental application for febuxostat filed by Zydus Lifesciences Limited under the ANDA.

• FDA approval · 2023-09-18
  FDA Approved: ALLOPURINOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for allopurinol submitted by Mylan Pharmaceuticals Inc. (ANDA 018659).

• FDA approval · 2023-08-15
  FDA Approved: FEBUXOSTAT — Supplemental Application (Novadoz Pharmaceuticals LLC)

  FDA approved a supplemental application for febuxostat from Novadoz Pharmaceuticals LLC.

• FDA approval · 2023-08-15
  FDA Approved: FEBUXOSTAT — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for febuxostat submitted by Ascend Laboratories, LLC.

• FDA approval · 2023-08-09
  FDA Approved: FEBUXOSTAT — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Febuxostat submitted by Sun Pharmaceutical Industries, Inc.