Vanda Pharma says FDA is in violation of FDCA regarding its Hetlioz sNDA

US drugmaker Vanda Pharmaceuticals (Nasdaq: VNDA) saw its shares close down 3% yesterday and fall a further 2.2% to $4.04 pre-market on news of a setback for its Hetlioz (tasimelteon)

Vanda announced that, on February 4, it received a notification from the US Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for Hetlioz in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. In a letter to Vanda dated July 17, 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA. Vanda says it has extensively studied the efficacy of Hetlioz in the treatment of insomnia characterized by difficulties with sleep initiation.