UPDATE: Vanda Pharmaceuticals Halted for FDA Advisory Committee to Review HETLIOZ NDA
Vanda Pharmaceuticals (VANDA) (NASDAQ: VNDA) today announced that NASDAQ halted trading of Vanda common stock this morning.
The Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) meets today to review Vanda's New Drug Application (NDA) for tasimelteon, proposed trade name HETLIOZ™, for the treatment of Non-24-Hour Disorder in the totally blind. The Advisory Committee meeting is scheduled for 8:00 am ET.
Vanda's HETLIOZ™ 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.
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SOURCE Vanda Pharmaceuticals Inc.