Raptor Pharmaceutical (RPTP) says the FDA will require additional time to complete its review of...

|About: Raptor Pharmaceutical Corp. (RPTP)|By:, SA News Editor

Raptor Pharmaceutical (RPTP) says the FDA will require additional time to complete its review of the New Drug Application for RP103, Procysbi, for the potential treatment of nephropathic cystinosis. The company received notice today that the PDUFA goal date has been extended from January 30, 2013 to April 30, 2013in order to provide more time to complete the review of information submitted. The agency hasn't asked for any additional studies.