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FDA Determines VYVANSE was Properly Granted Five-Year Market Exclusivity
Shire, 10/27/09
Shire plc, the global specialty biopharmaceutical company, announces that the Food and Drug Administration, 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 exclusivity to lisdexamfetamine dimesylate—currently marketed by Shire U.S. Inc. for the treatment of attention–deficit hyperactivity disorder under the name VYVANSE.
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