Raptor Pharma Offers Update on PROCYSBI NDA Review
Raptor Pharmaceutical Corp. (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration ("FDA") will require additional time to complete its review of the New Drug Application ("NDA") for RP103 (PROCYSBI™), for the potential treatment of nephropathic cystinosis. In a notice received today from the FDA, the initial Prescription Drug User Fee Act ("PDUFA") goal date has been extended from January 30, 2013 to April 30, 2013. The three month extension is a standard extension period.
The FDA exercised its option to extend the PDUFA goal date to provide more time to complete the review of information submitted within three months of the PDUFA date. The agency has not asked for additional studies.
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