Vanda Pharmaceuticals (NASDAQ:VNDA) has received a notification from the FDA stating that as part of its ongoing review of sNDA for HETLIOZ (tasimelteon) for the treatment of Jet Lag Disorder, the agency has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time.
No deficiencies were disclosed and this notification does not reflect a final decision.
The FDA had assigned a PDUFA target date for completion of its review by August 16, 2019.
Vanda anticipates receiving additional communication from the FDA identifying specific deficiencies in the sNDA.
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