Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)

Resumen

The Food and Drug Administration (FDA or the Agency) 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. (Vanda) for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), to treat jet lag disorder. On October 11, 2022, the Director of FDA's Center for Drug Evaluation and Research (CDER) published a notice of opportunity for hearing on a proposal to refuse to approve sNDA 205677-004. Vanda submitted a timely request for hearing on that proposal. This notice of hearing provides factual and legal information concerning CDER's proposal to refuse to approve sNDA 205677-004 and identifies the factual issues that will be the subject of the evidentiary hearing.