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news.Raptor Pharmaceutical has submitted a new drug application (NDA) to the FDA for marketing approval of Cysteamine Bitartrate delayed-release capsules (RP103), to treat nephropathic cystinosis.
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Raptor has appealed for priority review of the NDA, which, if granted, could lead to a decision for marketing approval of RP103 in the fourth calendar quarter of 2012.
The application includes data from Raptor’s Phase III clinical trial of RP103, which met its sole primary endpoint and did not find any unexpected serious safety concerns.
Raptor chief executive officer Christopher Starr said: We could not be more pleased to have now submitted both our NDA, as well as our MAA to the EMA, of RP103 for the potential treatment of cystinosis, by taking advantage of the newly recommended electronic Common Technical Document ("eCTD") format."