Gout
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-03-10FDA Approved: COLCHICINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original ANDA for colchicine from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), providing a generic version of…
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FDA approval · 2022-03-07FDA Approved: ALLOPURINOL — Original Application (Harman Finochem Limited)
FDA approves the original application for Allopurinol from Harman Finochem Limited.
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CLINICAL_TRIALS trial_result · 2022-02-23Clinical Trial Update: SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study [NA]
Completed clinical trial STRIDE-GO2 evaluating strategies to improve outcomes in gout with low medication adherence; results posted in 2022.
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FDA approval · 2022-02-17FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC.
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CLINICAL_TRIALS trial_result · 2022-02-14Clinical Trial Update: Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid [Phase 2]
Phase 2 multi-dose safety and pharmacodynamic study of SEL-212/SEL-037 in symptomatic gout with hyperuricemia has completed with results pos…
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FDA approval · 2022-01-26FDA Approved: ALLOPURINOL — Original Application (Gland Pharma Limited)
FDA approved the original application for allopurinol from Gland Pharma Limited, enabling a generic version in the United States.
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CLINICAL_TRIALS trial_result · 2022-01-11Clinical Trial Update: CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat [Phase 4]
A Phase 4 comparative effectiveness trial comparing allopurinol vs febuxostat in gout patients, including those with chronic kidney disease;…
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FDA approval · 2022-01-06FDA Approved: COLCHICINE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original application for a generic colchicine product. This approval recognizes a generic colchi…
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FDA approval · 2021-12-07FDA Approved: FEBUXOSTAT — Original Application (Ascend Laboratories, LLC)
The FDA approved Ascend Laboratories, LLC's original application for febuxostat, a generic version of the gout and hyperuricemia medication.
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CLINICAL_TRIALS trial_result · 2021-11-10Clinical Trial Update: REduCing Immunogenicity to PegloticasE (RECIPE) Study [Phase 2]
Phase 2 clinical trial RECIPE studying reducing immunogenicity to PegloticasE for gout chronic has completed with results posted.
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CLINICAL_TRIALS trial_result · 2021-11-05Clinical Trial Update: Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients [Phase 2]
Phase 2 placebo-controlled trial evaluating safety, tolerability, PK, and PD of SAP-001 in gout patients with hyperuricemia completed.
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CLINICAL_TRIALS trial_result · 2021-11-04Clinical Trial Update: A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment [Phase 4]
A Phase 4 safety and efficacy trial of lesinurad 200 mg in participants with gout and renal impairment was terminated; results were posted i…
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CLINICAL_TRIALS trial_result · 2021-10-11Clinical Trial Update: Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect [Phase 2]
Phase 2 trial evaluating tolerization to reduce intolerance to pegloticase and prolong urate-lowering effect in gout.
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CLINICAL_TRIALS trial_result · 2021-08-31Clinical Trial Update: Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions [Phase 2]
Phase 2 trial evaluating denosumab in addition to intense urate-lowering therapy for bone erosions in gout patients has completed with poste…
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FDA approval · 2021-08-13FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original ANDA for colchicine, authorizing a generic version of the drug.
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FDA approval · 2021-08-12FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)
FDA approved the original application for colchicine (generic) from Par Health USA, LLC.
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FDA approval · 2021-04-28FDA Approved: NAPROXEN — Supplemental Application (Acella Pharmaceuticals, LLC)
The FDA approved a supplemental application for Naproxen filed by Acella Pharmaceuticals, LLC, updating the product's approval status.
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FDA approval · 2021-04-28FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…
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FDA approval · 2021-04-26FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.
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CLINICAL_TRIALS trial_result · 2021-03-30Clinical Trial Update: The Diet Gout Trial [NA]
Clinical trial update for a diet-based intervention in gout and hyperuricemia, with completed status and results posted.
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CLINICAL_TRIALS trial_result · 2021-03-18Clinical Trial Update: Study of of URC102 to Assess the Efficacy and Safety in Gout Patients [Phase 2]
Phase 2 clinical trial of URC102 in gout has completed; efficacy and safety results are reported.
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FDA approval · 2020-12-16FDA Approved: ALOPRIM — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for ALOPRIM (allopurinol) submitted by Mylan Institutional LLC.
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FDA approval · 2020-12-12FDA Approved: NAPROXEN SODIUM — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for Naproxen Sodium from Bionpharma Inc., resulting in changes to the product labeling. This act…
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CLINICAL_TRIALS trial_result · 2020-11-19Clinical Trial Update: Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients [Phase 2]
Phase 2a study of AR882, alone and with febuxostat or allopurinol, in gout patients completed.
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CLINICAL_TRIALS trial_result · 2020-11-18Clinical Trial Update: Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout [Phase 4]
A Phase 4 trial evaluating pegylated uricase (pegloticase) plus methotrexate for uncontrolled gout has completed, with results posted.