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Data updated: Mar 10, 2026

LITHOSTAT

ACETOHYDROXAMIC ACID Urease Inhibitors
Infectious Disease Approved 1983-05-31
1
Indication
--
Phase 3 Trials
1
Priority Reviews
42
Years on Market

Details

Status
Prescription
First Approved
1983-05-31
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ACETOHYDROXAMIC ACID

LITHOSTAT Approval History

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What LITHOSTAT Treats

1 indications

LITHOSTAT 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
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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

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Indications & 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.