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July 29, 2013
20:01 EDTVNDAVanda says FDA grants priority review for tasimelteon NDA
Vanda Pharmaceuticals announced that the U.S. FDA has accepted the filing and granted a priority review classification to Vanda's New Drug Application for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder in the totally blind. The FDA determined the action target date under Prescription Drug User Fee Act, to be January 31, 2014. The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14.
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