Gout
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-10-28FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new gelcap dosage form for naproxen sodium, expanding th…
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CLINICAL_TRIALS trial_result · 2020-10-28Clinical Trial Update: A Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Gout [Phase 2]
Phase 2 trial update for AC-201 controlled-release tablet in gout has completed with posted results.
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FDA approval · 2020-10-22FDA Approved: FEBUXOSTAT — Original Application (DR REDDY'S LABORATORIES LIMITED)
FDA approved a generic febuxostat product from Dr. Reddy's Laboratories Limited via an Original Application (ANDA).
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FDA approval · 2020-08-28FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC. The action relates to updates in the…
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FDA approval · 2020-07-28FDA Approved: NAPROXEN — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for Naproxen from Glenmark Pharmaceuticals to update the labeling for the generic product under the …
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CLINICAL_TRIALS trial_result · 2020-06-23Clinical Trial Update: The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics [Phase 4]
Phase 4 trial investigating how BCRP Q141K affects allopurinol pharmacokinetics and pharmacodynamics in chronic gout and hyperuricemia. Comp…
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FDA approval · 2020-06-02FDA Approved: FEBUXOSTAT — Original Application (HEC Pharm USA Inc.)
The FDA approved the original application for febuxostat submitted by HEC Pharm USA Inc., authorizing a generic version of febuxostat. Febux…
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FDA approval · 2020-03-30FDA Approved: COLCHICINE — Supplemental Application (Dr.Reddys Laboratories, Inc.)
FDA approved a supplemental application for Colchicine submitted by Dr. Reddy's Laboratories, Inc.
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FDA approval · 2020-03-19FDA Approved: NAPROXEN — Supplemental Application (Aurobindo Pharma Limited)
FDA approves Aurobindo Pharma Limited's supplemental application for naproxen (generic) under ANDA075390. This action constitutes a suppleme…
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FDA approval · 2019-12-30FDA Approved: FEBUXOSTAT — Original Application (Novadoz Pharmaceuticals LLC)
FDA approved the original Abbreviated New Drug Application for febuxostat (generic) by Novadoz Pharmaceuticals LLC.
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FDA approval · 2019-12-30FDA Approved: FEBUXOSTAT — Original Application (Tris Pharma Inc)
The FDA approved an original application for febuxostat from Tris Pharma Inc, representing a generic product. The approval covers febuxostat…
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CLINICAL_TRIALS trial_result · 2019-12-16Clinical Trial Update: Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure [Phase 4]
Phase 4 clinical trial update evaluating the effect of febuxostat on blood pressure in patients with high normal blood pressure and gout; st…
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FDA approval · 2019-11-22FDA Approved: NAPROXEN SODIUM — Supplemental Application (CVS)
FDA approved a supplemental application for Naproxen Sodium from CVS under ANDA 091353, resulting in updated approval for the product.
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FDA approval · 2019-11-15FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic Naproxen product from Hikma Pharmaceuticals USA Inc. This action expands access to…
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FDA approval · 2019-11-14FDA Approved: COLCHICINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for COLCHICINE from Zydus Lifesciences Limited. This indicates a supplemental approval for this gene…
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CLINICAL_TRIALS trial_result · 2019-11-12Clinical Trial Update: Virtual Gout Clinic [NA]
A completed clinical trial for a virtual gout clinic sponsored by the University of Alabama at Birmingham with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-10-28Clinical Trial Update: Novel Methods for Ascertainment of Gout Flares -A Pilot Study [NA]
Pilot study exploring novel methods for ascertainment of gout flares; completed with results posted in 2019.
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FDA approval · 2019-10-26FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in an approved modification to the product’s lab…
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FDA approval · 2019-10-15FDA Approved: FEBUXOSTAT — Original Application (Hikma Pharmaceuticals USA Inc)
FDA approved Hikma Pharmaceuticals USA Inc for a generic febuxostat via an original ANDA (ANDA205414). This approval expands access to urate…
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CLINICAL_TRIALS trial_result · 2019-09-24Clinical Trial Update: Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia [Phase 2]
Phase II dose-finding study of RDEA3170 versus placebo in Japanese patients with gout or asymptomatic hyperuricemia completed with results p…
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FDA approval · 2019-09-16FDA Approved: COLCHICINE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved a generic colchicine product from Mylan Pharmaceuticals Inc. under an original ANDA (ANDA209470).
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FDA approval · 2019-09-06FDA Approved: COLCHICINE — Original Application (Dr.Reddys Laboratories, Inc.)
FDA approves Dr. Reddy's Laboratories' original ANDA for colchicine, enabling sale of a generic colchicine product.
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CLINICAL_TRIALS trial_result · 2019-08-07Clinical Trial Update: An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels. [Phase 4]
Phase 4 clinical trial assessing chronic synovial inflammation and its relationship with serum urate levels in gout, with results posted.
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FDA approval · 2019-07-01FDA Approved: FEBUXOSTAT — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' original application for febuxostat (generic febuxostat). This ANDA approval provides a generic …
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FDA approval · 2019-07-01FDA Approved: FEBUXOSTAT — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic Pharmaceuticals Limited's original ANDA for febuxostat, a generic version of the gout and hyperuricemia therapy.