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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 ...
Posted 30 Apr 2013 by Drugs.com
April 30, 2013 – The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition. Cystinosis is a rare genetic condition that affects an estimated 500 patients in the United States and about 3,000 ...
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
Posted 9 Oct 2012 by Drugs.com
GAITHERSBURG, MD, October 04, 2012 —Sigma-Tau Pharmaceuticals, Inc. announced today that the Company has received approval from the U.S. Food & Drug Administration (FDA) for Cystaran (cysteamine ophthalmic solution) 0.44%, a topical ophthalmic therapeutic, developed in partnership with the National Institutes of Health (NIH), for the treatment of patients suffering from corneal cystine crystal a ...