Gout
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2019-06-21Clinical Trial Update: Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout [Phase 4]
Phase 4 trial comparing intensive urate lowering with febuxostat vs allopurinol to assess cardiovascular risk in gout patients; results post…
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FDA label_change · 2019-04-23FDA Approved: ALLOPURINOL — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for allopurinol submitted by Zydus Lifesciences Limited, indicating changes to the product labeling.
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FDA approval · 2019-04-23FDA Approved: ALLOPURINOL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Allopurinol from Mylan Pharmaceuticals Inc., representing a supplemental approval for the produc…
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FDA approval · 2019-03-19FDA Approved: ALLOPURINOL — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for allopurinol (generic) submitted by Chartwell RX, LLC.
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FDA approval · 2019-03-12FDA Approved: ALLOPURINOL — Original Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for Allopurinol, a generic drug used to treat gout and hyperuric…
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FDA approval · 2019-02-21FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ULORIC (febuxostat) from Takeda Pharmaceuticals America, Inc., reflecting an additional regulato…
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FDA approval · 2019-02-19FDA Approved: COLCHICINE — Original Application (Zydus Lifesciences Limited)
FDA approved an original application for Colchicine from Zydus Lifesciences Limited, enabling a generic version of the drug to reach the mar…
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FDA approval · 2019-02-08FDA Approved: COLCHICINE — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories, LLC's original ANDA application for Colchicine, making a generic colchicine product available in the U.S.
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FDA approval · 2019-01-30FDA Approved: GLOPERBA — Original Application (Scilex Pharmaceuticals Inc.)
The FDA approved GLOPERBA, a colchicine oral solution from Scilex, marking the original application approval for this colchicine product.
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CLINICAL_TRIALS trial_result · 2019-01-11Clinical Trial Update: Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
An observational study evaluating the use of pegloticase (KRYSTEXXA) in patients with refractory chronic gout; study completed with results …
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FDA approval · 2018-12-03FDA Approved: ALLOPURINOL — Supplemental Application (Rising Pharma Holdings, Inc.)
The FDA approved a supplemental application for Allopurinol filed by Rising Pharma Holdings, Inc.
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FDA approval · 2018-11-29FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., confirming regulatory clearance for an updated product-rel…
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FDA approval · 2018-11-29FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)
The FDA approved an original ANDA for colchicine from Par Health USA, LLC, enabling the marketing of a generic colchicine product. This repr…
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FDA approval · 2018-11-16FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)
The FDA approved a supplemental application for MITIGARE (colchicine) filed by Hikma Specialty USA Inc.
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CLINICAL_TRIALS research · 2018-07-26Clinical Trial Update: The Percentage of Cases of Acute Treatment With Allopurinol in Gout Patients [NA]
Clinical trial update on the use of allopurinol for acute treatment in gout patients. The current status of the study is UNKNOWN.
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FDA approval · 2018-07-25FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
The FDA approved Bayer's supplemental application to add ALEVE GELCAPS (naproxen sodium) as an additional formulation of naproxen products.
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FDA approval · 2018-07-13FDA Approved: KRYSTEXXA — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA has approved a supplemental application for KRYSTEXXA (pegloticase) from Horizon Therapeutics USA, Inc.
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CLINICAL_TRIALS trial_result · 2018-07-03Clinical Trial Update: A Single Dose Study of SHR4640 in Healthy Male Volunteers [Phase 1]
A Phase 1 single-dose study of SHR4640 in healthy male volunteers has completed. The sponsor is Atridia Pty Ltd.
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CLINICAL_TRIALS trial_result · 2018-06-14Clinical Trial Update: Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) [Phase 3]
A Phase 3 trial (CARES) comparing the cardiovascular safety of febuxostat versus allopurinol in gout patients with cardiovascular comorbidit…
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CLINICAL_TRIALS withdrawal · 2018-04-02Clinical Trial Update: Apremilast Therapy for Acute Gouty Arthritis [Phase 2]
A Phase 2 trial evaluating apremilast for acute gouty arthritis has been withdrawn.
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CLINICAL_TRIALS trial_result · 2018-03-21Clinical Trial Update: Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level [Phase 1]
A Phase 1 multiple-dose study of SHR4640 in male subjects with high serum uric acid levels has completed.
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FDA label_change · 2018-02-06FDA Approved: ULORIC — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for ULORIC (febuxostat) submitted by Takeda Pharmaceuticals America, Inc. The supplemental action pe…
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CLINICAL_TRIALS trial_result · 2018-02-05Clinical Trial Update: Colchicine Or Naproxen Treatment for ACute gouT [Phase 4]
Phase 4 clinical trial update evaluating colchicine or naproxen treatment for acute gout; study completed with results posted in 2018.
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CLINICAL_TRIALS trial_result · 2018-01-30Clinical Trial Update: Lesinurad and Febuxostat Combination Extension Study in Gout [Phase 3]
Phase 3 trial update for a lesinurad and febuxostat combination in gout has completed with results posted.
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CLINICAL_TRIALS trial_result · 2018-01-29Clinical Trial Update: Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients [Phase 2]
Phase 2 clinical trial update evaluating arhalofenate for preventing flares and lowering serum uric acid in gout patients.