Raptor Pharmaceutical Corp. (RPTP) announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application or "NDA" for its investigational drug candidate, Cysteamine Bitartrate Delayed-release Capsules or "RP103", for the potential treatment of nephropathic cystinosis. The FDA has granted Standard Review designation for RP103.
Previously, Raptor announced that the European Medicines Agency or "EMA" had validated its Marketing Authorization Application or "MAA" for RP103 for the potential treatment of nephropathic cystinosis. Raptor's MAA is under review by the EMA, and the Company expects a decision in the first half of 2013.
Cystinosis patients have inherited a defective cystine transporter gene which results in body-wide cellular toxicity resulting from the abnormal buildup of the amino acid cystine in the lysosomes.
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