Federal Register #FDA2022N2390

FDA Public Hearing on Vanda Pharmaceuticals' HETLIOZ (Tasimelteon) sNDA for Jet Lag Disorder

This notice announces a regulatory hearing, not a procurement opportunity, by the Food and Drug Administration (FDA) regarding Vanda Pharmaceuticals' supplemental new drug application (sNDA) for HETLIOZ (tasimelteon) capsules, 20 mg, for jet lag disorder. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM/Vendor: - Vanda Pharmaceuticals Inc. (only OEM mentioned) - Products/Services: - No products or services are being procured or awarded; the event concerns a regulatory review of HETLIOZ (tasimelteon) capsules, 20 mg - Notable Requirements: - The hearing will address whether Vanda has provided substantial evidence of effectiveness for the proposed indication - The event is a formal evidentiary public hearing, presided over by an Administrative Law Judge - Participation requires submission of evidence and notices by specified deadlines - The hearing is open to the public via live stream - No contract value, product line items, or service line items are associated with this notice - Locations involved are FDA offices in Rockville and Silver Spring, Maryland

Description

The Food and Drug Administration (FDA) is announcing a formal evidentiary public hearing on the proposal to refuse to approve the supplemental new drug application (sNDA) 205677-004 submitted by Vanda Pharmaceuticals Inc. for HETLIOZ (tasimelteon) capsules, 20 mg, to treat jet lag disorder. The hearing will address whether Vanda has provided substantial evidence that the drug is effective for the treatment of jet lag disorder, focusing on specific factual issues identified by the FDA's Center for Drug Evaluation and Research (CDER). Key dates include a prehearing conference on July 20, 2026, and deadlines for participation and data disclosure in July and August 2026 respectively.

View original listing