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

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-N-2390] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. DATES: A prehearing conference will be held on July 20, 2026, beginning at 10 a.m. Eastern Daylight Time. Any person wishing to participate in this hearing shall submit a written notice of participation by July 6, 2026. Disclosure of data and information as required by 21 CFR 12.85(b) must be made by August 3, 2026. ADDRESSES: You may submit a written notice of participation and data and information required under 21 CFR 12.85 by either of the following methods: Electronic Submissions Submit electronically in the following way: Federal …