Alcobra Release: FDA Grants Orphan Drug Status To Metadoxine In Fragile X Syndrome
Published: Dec 19, 2013
TEL AVIV, Israel, Dec. 18, 2013 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD) (the "Company"), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Sustained-Release Metadoxine), to treat cognitive dysfunction, announced today that the U.S. Food & Drug Administration has granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, as well as an extended period of market exclusivity following approval.
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