tiopronin
Drug Details
- Generic Name
- tiopronin
- Brand Names
- Thiola, Thiola EC, VENXXIVA, tiopronin, TIOPRONIN
- Application Number
- NDA019569
- Sponsor
- Mission Pharmacal Company
- NDC Codes
- 8
- Dosage Forms
- TABLET, SUGAR COATED, TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- TIOPRONIN
Indications and Usage
1 INDICATIONS AND USAGE VENXXIVA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. VENXXIVA is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. ( 1 )