Vanda Pharmaceuticals Announces FDA Advisory Committee Meeting On November 14, 2013

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Vanda Pharmaceuticals Inc. (VANDA)
VNDA
today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the scheduling of a Peripheral and Central Nervous System Drugs Advisory Committee meeting on November 14, 2013, for the review of Vanda's New Drug Application (NDA) for tasimelteon, proposed trade name HETLIOZ™, for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind.  Vanda's tasimelteon NDA is currently under Priority Review by the FDA with an action target date under the Prescription Drug User Fee Act (PDUFA-V) of January 31, 2014.   About Non-24-Hour DisorderNon-24 is a serious, rare, and chronic circadian rhythm disorder characterized by the inability to entrain (synchronize) the master body clock with the 24-hour day-night cycle.  Non-24 affects a majority of totally blind individuals, or between 65,000 and 95,000 people in the U.S.  Non-24 occurs almost entirely in individuals who lack the light sensitivity necessary to entrain the master body clock in the brain with the 24-hour day-night cycle.  Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day.  Individuals with Non-24
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Posted In: NewsFDA
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