QUININE SULFATE
QUININE SULFATE is indicated for the treatment of Malaria.
Details
- Status
- Prescription
- First Approved
- 2012-09-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
QUININE SULFATE Approval History
What QUININE SULFATE Treats
1 indicationsQUININE SULFATE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Malaria
QUININE SULFATE Boxed Warning
HEMATOLOGIC REACTIONS [see FULL PRESCRIBING INFORMATION for complete boxed warning] Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with quinine sulfate capsules use in the absence of eviden...
WARNING: HEMATOLOGIC REACTIONS [see FULL PRESCRIBING INFORMATION for complete boxed warning] Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with quinine sulfate capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit ( 5.1 ) . WARNING: HEMATOLOGIC REACTIONS Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with quinine sulfate capsules use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit [see WARNINGS AND PRECAUTIONS ( 5.1 )].
QUININE SULFATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02630472 QSIND results posted | 821731 | Ph 1, Ph 2 | terminated | Topical Irrigation Therapy for CRS |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
QUININE SULFATE FDA Label Details
Indications & Usage
QUININE SULFATE is indicated for the treatment of Malaria.
WARNING: HEMATOLOGIC REACTIONS [see FULL PRESCRIBING INFORMATION for complete boxed warning] Quinine sulfate capsules use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome...
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Full clinical data, patents, trials, and competitive landscape for quinine sulfate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.