28 June 2019 - Enteric-coated formulation offers flexible dosing options, including administration with or without food.

Retrophin today announced that the U.S. FDA has approved 100 mg and 300 mg tablets of Thiola EC (tiopronin), a new enteric-coated formulation of Thiola (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones. Thiola EC is expected to be available in July 2019.

Thiola tablets were approved through the 505(b)(2) regulatory pathway which allows the FDA to reference previous findings of safety and efficacy for an already-approved product, combined with reviewing findings from further studies of the product.

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