Gout
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2009-11-20Clinical Trial Update: Pharmacokinetic Study of an Acute Gout Regimen [Phase 1]
Phase 1 pharmacokinetic study of an acute gout regimen completed; results posted in 2009.
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CLINICAL_TRIALS trial_result · 2009-09-22Clinical Trial Update: MPC-004 for the Treatment of an Acute Gout Flare [Phase 3]
Phase 3 clinical trial update reporting completion and results posting for MPC-004 in acute gout flare.
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CLINICAL_TRIALS trial_result · 2009-09-07Clinical Trial Update: Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010 [Phase 3]
Phase 3 trial update comparing allopurinol and febuxostat in subjects completing trials C02-009 and C02-010; results were posted in 2009.
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FDA approval · 2009-07-29FDA Approved: COLCRYS — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA's original approval package for COLCRYS (colchicine) from Takeda Pharmaceuticals America, Inc., detailing the initial NDA approval of co…
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Febuxostat Versus Allopurinol Control Trial in Subjects With Gout [Phase 3]
Phase 3 randomized trial comparing febuxostat to allopurinol in gout patients, with results posted in 2009.
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. [Phase 3]
A Phase 3, randomized, placebo-controlled trial comparing febuxostat and allopurinol in gout subjects has completed and results have been po…
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Efficacy and Safety of Oral Febuxostat in Participants With Gout [Phase 3]
A Phase 3 clinical trial evaluating the efficacy and safety of oral febuxostat in participants with gout has completed, with results posted …
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Long-Term Safety of Febuxostat in Subjects With Gout. [Phase 2]
Phase 2 long-term safety results for febuxostat in gout patients; the trial was completed and results were posted in 2009.
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout [Phase 2]
Phase 2 trial evaluating dose-response, safety, and efficacy of febuxostat in patients with gout. Results were posted in 2009.
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Validation Study of Physical Measurement of Tophi
A completed validation study assessing the accuracy of physically measuring gout-related tophi. Results have been posted by Takeda.
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CLINICAL_TRIALS trial_result · 2009-07-16Clinical Trial Update: Magnetic Resonance Imaging in Subjects With Gouty Tophi
Takeda-sponsored clinical trial results assess magnetic resonance imaging (MRI) in subjects with gouty tophi and hyperuricemia.
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FDA approval · 2009-03-06FDA Approved: INDOMETHACIN — Original Application (KVK-Tech, Inc.)
FDA approved an original application for Indomethacin by KVK-Tech, Inc., establishing a generic version of indomethacin. The approval signif…
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FDA approval · 2009-02-13FDA Approved: ULORIC — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved ULORIC (febuxostat) as the original application to treat hyperuricemia associated with gout by lowering serum uric acid levels.…
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FDA approval · 2009-01-23FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for allopurinol from Actavis Pharma, updating the existing NDA.
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FDA approval · 2009-01-23FDA Approved: ALLOPURINOL — Supplemental Application (Actavis Pharma, Inc.)
FDA approves a supplemental application for Allopurinol submitted by Actavis Pharma, Inc.
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CLINICAL_TRIALS trial_result · 2009-01-13Clinical Trial Update: Phase III Trial of Febuxostat in Korea Gout Patients [Phase 3]
Phase 3 trial of febuxostat in Korean gout patients has completed. The snippet does not report trial results.
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FDA approval · 2008-10-29FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)
FDA approved a supplemental application from Granules India Ltd for Naproxen (Naproxen sodium) granules. This adds a granulated dosage form …
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FDA approval · 2008-07-25FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)
The FDA has approved a supplemental application for naproxen filed by Zameer Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2008-06-09Clinical Trial Update: MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs [NA]
This completed study examined MRI and ultrasound findings in gout patients with normal plain radiographs to characterize imaging features of…
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FDA approval · 2008-05-13FDA Approved: PROBENECID AND COLCHICINE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved Ingenus Pharmaceuticals' generic Probenecid and Colchicine as an original ANDA.
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FDA approval · 2007-11-07FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…
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FDA approval · 2007-09-25FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…
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FDA approval · 2007-08-22FDA Approved: ALLOPURINOL — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for allopurinol (ALLOPURINOL) from Sun Pharmaceutical Industries, Inc. The action represents a regul…
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FDA approval · 2007-07-26FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…
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FDA approval · 2007-07-15FDA Approved: NAPROXEN — Supplemental Application (Granules India Ltd)
The FDA approved Granules India Ltd's supplemental application for Naproxen (naproxen sodium). This action approves a generic naproxen sodiu…