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# FDA Accepts NDA for New Thiola Formulation
- URL: https://www.fdaweb.com/fda-accepts-nda-for-new-thiola-formulation/
- Published: 2018-11-12T12:00:00.000Z
- Updated: 2026-09-15T00:43:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142793

FDA has accepted for review a Retrophin NDA for a new formulation of its Thiola (tiopronin) tablets for treating cystinuria. The agency has set a user fee review action target date of 6/30/2019\. The 505(b)(2) NDA was submitted by the company’s partner, Mission Pharmacal. Thiola (tiopronin) tablets are indicated for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria with urinary cystine (greater than 500 mg/day), who are resistant to treatment with conservative measures of high fluid intake, alkali and diet modification, or who have adverse reactions to d-penicillamine.