Raptor Pharmaceutical Corp Submits New Drug Application For RP103 For Potential Treatment Of Nephropathic Cystinosis

Raptor Pharmaceutical Corp announced that it submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules (RP103), for the potential treatment of nephropathic cystinosis. In its application, Raptor has requested Priority Review of the NDA, which, if granted, could lead to a decision for marketing approval from the FDA of RP103 for the potential treatment of nephropathic cystinosis in the fourth calendar quarter of 2012. Earlier on March 26, Raptor announced European Medicines Agency validation of its Marketing Authorization Application for RP103 for the potential treatment of nephropathic cystinosis.