Gout
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-19EMA Authorised: Febuxostat Viatris (previously Febuxostat Mylan) (febuxostat) — Viatris Limited
European Medicines Agency authorised Febuxostat Viatris for hyperuricemia and gout-related indications.
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FDA approval · 2026-08-07FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA supplemental application review for KRYSTEXXA (pegloticase) submitted by Horizon Therapeutics USA, Inc.
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EMA approval · 2026-02-26EMA Authorised: Adenuric (febuxostat) — Menarini International Operations Luxembourg S.A. (MIOL)
The EMA authorised Adenuric (febuxostat) for the treatment of gout; the marketing authorization holder is Menarini International Operations …
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FDA approval · 2026-02-17FDA Approved: COLCHICINE — Original Application (Micro Labs Limited)
FDA approved the original ANDA for colchicine (Colchicine) from Micro Labs Limited, enabling a generic version of the drug. The approval con…
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EMA approval · 2025-10-13EMA Authorised: Ilaris (Canakinumab) — Novartis Europharm Limited
The EMA authorised Ilaris (canakinumab) for use in Cryopyrin-Associated Periodic Syndromes, juvenile idiopathic arthritis, and gout.
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FDA approval · 2025-10-03FDA Approved: NAPROXEN — Original Application (Aurobindo Pharma Limited)
FDA approved Naproxen from Aurobindo Pharma Limited as an original generic application (ANDA 216504). Naproxen is a nonsteroidal anti-inflam…
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EMA approval · 2025-07-14EMA 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.
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FDA approval · 2025-07-01FDA Approved: COLCHICINE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Colchicine from Par Health USA, LLC. The action likely updates the product’s labeling or indicat…
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FDA approval · 2025-06-13FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Allopurinol from Zydus Lifesciences Limited.
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FDA approval · 2025-04-14FDA Approved: ALLOPURINOL — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for Allopurinol from Aurobindo Pharma Limited, authorizing a generic version of allopurinol.
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EMA approval · 2025-03-27EMA 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 · 2025-03-14FDA Approved: COLCHICINE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for colchicine submitted by Par Health USA, LLC. The action pertains to the generic colchicine produ…
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FDA approval · 2025-02-15FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen (ANDA074190) from Hikma Pharmaceuticals USA Inc., resulting in an updated approval of t…
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FDA approval · 2025-02-11FDA 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…
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FDA approval · 2024-12-12FDA Approved: COLCHICINE — Supplemental Application (Granules Pharmaceutical Inc.)
The FDA approved a supplemental application for Colchicine from Granules Pharmaceutical Inc., updating the approved Colchicine product.
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FDA approval · 2024-11-21FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.
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FDA approval · 2024-11-21FDA 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…
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FDA approval · 2024-10-11FDA Approved: COLCHICINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Colchicine from Camber Pharmaceuticals, Inc., resulting in an approved change to an existing…
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FDA approval · 2024-08-30FDA 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 …
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FDA approval · 2024-07-22FDA 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…
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FDA approval · 2024-05-16FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)
FDA approved a supplemental application for Mitigare (colchicine) submitted by Hikma Specialty USA Inc. The action updates the product label…
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Granules Pharmaceutical Inc.)
FDA approved an Original Application for a generic colchicine product by Granules Pharmaceutical Inc., establishing a generic option for col…
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals’ generic colchicine under an original ANDA, authorizing its marketing as a generic product.
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for a generic colchicine product.
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FDA approval · 2024-04-03FDA 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.