Notice of the Denial of a 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) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-012, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of insomnia characterized by difficulties with sleep initiation. The decision, which also refuses approval of sNDA 205677-012, is available in the docket identified by the number in the heading of this document. FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931. SUPPLEMENTARY INFORMATION: I. Background On January 31, 2014, FDA approved new drug application (NDA) 205677 for HETLIOZ (tasimelteon) for treatment of non-24-hour sleep-wake disorder, a circadian-rhythm disorder that disproportionately afflicts individuals who are totally blind. On December 1, 2020, FDA approved NDA 214517 for HETLIOZ (tasimelteon) suspension for the treatment of nighttime sleep disturbances in pediatric patients with Smith-Magenis Syndrome, a rare genetic neurodevelopment disorder. On May 4, 2023, …