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Vanda Pharma receives FDA Update for HETLIOZ in the Treatment of Jet Lag Disorder

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Additional Information

Additional Relevant Details 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
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Catalyst Date
Occurred on:
Jul 22, 2019
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Related Keywords Hetlioz, Jet Lag