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Shire Plc
FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity
November 13th, 2009
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE®. The five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE is covered by United States patents which remain in effect until June 29, 2023. On February...
Source: Food & Drug Law Weekly (2009-11-13)
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