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FDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis
Posted 20 Aug 2015 by Drugs.com
NOVATO, Calif., Aug. 17, 2015 (GLOBE NEWSWIRE) – Raptor Pharmaceutical Corp. (NASDAQ:RPTP) today announced that the U.S. Food and Drug Administration (FDA) approved the expanded use of Procysbi (cysteamine bitartrate) delayed-release capsules to treat children two to six years of age with nephropathic cystinosis. The approved supplement was based on efficacy and safety data from an ongoing long-term extension study in which a cohort of children aged 2 to 6 years were enrolled and treated with Procysbi for 12 months. Additionally, data submitted as part of this supplement supported the long-term maintenance of white blood cell cystine levels and renal function in all age groups studied during extended treatment with Procysbi. Procysbi is now approved for the treatment of nephropathic cystinosis in adult and in pediatric patients 2 years of age and older in the U.S. Please see the full ... Read more