Vanda announces FDA identified deficiencies in HETLIOTZ sNDA
Vanda Pharmaceuticals announced that on July 19 it received a notification from the FDA stating that as part of its ongoing review of Vanda's supplemental New Drug Application, or sNDA, for HETLIOZ, or 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, or PDUFA, target date for completion of its review by August 16. Vanda anticipates receiving additional communication from the FDA identifying specific deficiencies in the sNDA. Vanda hopes that it will be able to work expeditiously with the FDA to resolve any such deficiencies.