Vanda Pharmaceuticals Inc. announced that on July 19, 2019, it received a notification from the U.S. Food and Drug Administration stating that as part of its ongoing review of Vanda’s supplemental New Drug Application for HETLIOZ® for the treatment of Jet Lag Disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.
July 22, 2019
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