Vanda Pharmaceuticals FDA Update for HETLIOZ® in the Treatment of Jet Lag Disorder
Vanda Pharmaceuticals Inc. (VNDA)
Last vanda pharmaceuticals inc. earnings: 2/25 04:01 pm
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Source: PR Newswire
WASHINGTON, July 22, 2019 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on July 19, 2019, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of Jet Lag Disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in this notification, and the FDA stated that this notification does not reflect a final decision on the information under review. In a letter dated December 19, 2018, the FDA had assigned a Prescription Drug User Fee Act ("PDUFA") target date for completion of its review by August 16, 2019.Vanda has extensively studied the efficacy of the circadian regulator Hetlioz® on Jet Lag Disorder (JLD), which occurs following rapid eastward transmeridian travel an
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