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Vanda Pharma's (VNDA) HETLIOZ (tasimelteon) in Jet Lag Disorder PDUFA date due August 16, 2019

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Additional Information

Clinical Data Update on Aug. 19, 2019: Vanda Pharmaceuticals Inc. today announced that on August 16 2019, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) for the treatment of Jet Lag Disorder (JLD).In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance.
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Related Keywords Hetlioz, Tasimelteon, Jet Lag