[Federal Register Volume 90, Number 44 (Friday, March 7, 2025)]
[Notices]
[Page 11542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-03697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2390]


Notice of the Denial of a Hearing Request Regarding a Proposal To 
Refuse To Approve a Supplemental New Drug Application for HETLIOZ 
(Tasimelteon)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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, 
Vanda submitted the sNDA that is the subject at issue here: sNDA 
205677-012 for HETLIOZ (tasimelteon) capsules, 20 mg, as an efficacy 
supplement proposing to add a new indication for the treatment of 
insomnia characterized by difficulties with sleep initiation.
    On March 4, 2024, CDER issued a complete response letter to Vanda 
stating that sNDA 205677-012 could not be approved in its present form 
because the application does not provide substantial evidence of 
effectiveness for tasimelteon for the proposed indication--treatment of 
insomnia characterized by difficulties with sleep initiation, nor does 
the application demonstrate that the drug is safe for this use. 
Following the complete response letter, in a letter dated April 11, 
2024, Vanda indicated that it wished to receive approval of its 
application or a notice of opportunity for a hearing (NOOH). On June 6, 
2024, CDER notified Vanda by electronic mail, providing it with a NOOH 
on a proposal to refuse to approve sNDA 205677-012. The NOOH was 
subsequently published in the Federal Register of June 7, 2024 (89 FR 
48647) and described the grounds on which the application failed to 
meet the criteria for approval under section 505(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)).
    On July 3, 2024, Vanda filed a notice of participation and 
requested a hearing, and, on August 6, 2024, Vanda submitted 
information, data, and analyses in support of that request. On October 
31, 2024, CDER submitted a proposed order denying Vanda's request for a 
hearing and refusing to approve the sNDA. On December 31, 2024, Vanda 
submitted a response to CDER's proposed order.
    After considering the parties' submissions, on February 28, 2025, 
FDA issued a decision denying Vanda's request for a hearing on CDER's 
proposal to refuse approval and refusing to approve sNDA 205677-012.

II. Electronic Access

    Persons with access to the internet may obtain the final decision 
at https://www.regulations.gov/docket/FDA-2022-N-2390. The final 
decision and other documents pertaining to the refusal to approve 
HETLIOZ (sNDA 205677-012) are available at https://www.regulations.gov 
under the docket number found in brackets in the heading of this 
document.

    Dated: March 4, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-03697 Filed 3-6-25; 8:45 am]
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