LITHOSTAT
Details
- Status
- Prescription
- First Approved
- 1983-05-31
- Routes
- ORAL
- Dosage Forms
- TABLET
LITHOSTAT Approval History
What LITHOSTAT Treats
1 indicationsLITHOSTAT is approved for 1 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
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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.
LITHOSTAT FDA Label Details
ProIndications & Usage
Acetohydroxamic acid is indicated as adjunctive therapy in patients with chronic urea-splitting urinary infection. AHA is intended to decrease urinary ammonia and alkalinity, but it should not be used in lieu of curative surgical treatment (for patients with stones) or antimicrobial treatment. Long-term treatment with AHA may be warranted to maintain urease inhibition as long as urea-splitting infection is present. Experience with AHA does not go beyond 7 years. A patient package insert should be distributed to each patient who receives AHA.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.