12 November 2018 - PDUFA date set for 30 June 2019.

Retrophin today announced that the U.S. FDA has accepted for review the new drug application for a new formulation of Thiola (tiopronin) in the treatment of cystinuria.

“We know that living with a rare kidney disorder like cystinuria can be a challenge so we have worked with the patient, caregiver and medical communities over the past several years to identify ways we can further enhance Thiola,” said Stephen Aselage, chief executive officer of Retrophin. “The acceptance of this NDA for review is an important milestone as we continue efforts to fulfill our ongoing commitment to support patients with cystinuria and deliver a new, more patient-friendly formulation of Thiola.”

The application was filed by the Company’s partner, Mission Pharmacal Company, through the 505(b)(2) regulatory pathway which allows the FDA to reference previous findings of safety and efficacy for an already-approved product, in addition to reviewing findings from further studies of the product.

Read Retrophin press release