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Raptor Pharmaceutical Corp's PROCYSBI Receives FDA Approval For Treatment Of Nephropathic Cystinosis

Wednesday, 1 May 2013 04:18pm EDT 

Raptor Pharmaceutical Corp announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death. 

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