Thiola EC FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 1, 2019.
FDA Approved: Yes (First approved June 28, 2019)
Brand name: Thiola EC
Generic name: tiopronin
Dosage form: Delayed-Release Tablets
Company: Retrophin, Inc.
Treatment for: Cystinuria
Thiola EC (tiopronin) is a reducing and complexing thiol indicated for the prevention of cystine stone formation in patients with cystinuria.
- Thiola EC is a new enteric-coated formulation of Thiola tablets.
- The enteric-coated tablet formulation provides patients with the freedom to administer Thiola EC with or without food, an advancement over the original formulation of Thiola which required dosing at least one hour before or two hours after meals.
- Thiola EC is supplied as 100 mg and 300 mg tablets, and the original formulation of Thiola is supplied as 100 mg tablets.
- The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1000 mg/day. Thiola EC also provides the potential to reduce the total number of tablets necessary to manage cystinuria compared to the original formulation of Thiola.
Development timeline for Thiola EC
|Jun 28, 2019||Approval FDA Approves Thiola EC (tiopronin) for the Treatment of Cystinuria|
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