[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Page 16001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04735]


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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 or the Agency) 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) 205677-004, submitted by Vanda Pharmaceuticals, Inc. 
(Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for 
the treatment of jet lag disorder. The decision, which also refuses 
approval of sNDA 205677-004, is available in the docket identified by 
the number in the heading of this document.

DATES: The decision was published in the docket on March 1, 2024.

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 October 16, 2018, Vanda submitted 
the supplemental NDA (sNDA) that is the subject at issue here: sNDA 
205677-004 for HETLIOZ (tasimelteon) capsules, 20 mg, proposing to add 
a new indication for the treatment of jet lag disorder. 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 July 1, 2022, Vanda requested an opportunity for a hearing under 
21 CFR 314.110(b)(3) on whether there are grounds under section 505(d) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d)) for 
denying approval of sNDA 205677-004 for the treatment of jet lag 
disorder. On August 29, 2022, CDER notified Vanda by registered mail, 
providing it with a notice of opportunity for a hearing (NOOH) on a 
proposal to refuse to approve sNDA 205677-004. The NOOH was 
subsequently published in the Federal Register of October 11, 2022 (87 
FR 61337).
    On November 10, 2022, Vanda filed a notice of participation and 
requested a hearing and, on December 12, 2022, submitted information, 
data, and analyses in support of that request. On June 12, 2023, CDER 
submitted a proposed order denying Vanda's request for a hearing and 
refusing to approve the sNDA. On August 11, 2023, Vanda responded to 
CDER's proposed order. On September 8, 2023, CDER submitted a reply, 
which included a revised proposed order.
    After considering the parties' submissions, on March 1, 2024, FDA 
issued a decision denying Vanda's request for a hearing on CDER's 
proposal to refuse approval and refusing to approve sNDA 205677-004.

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 205677-004) are available at https://www.regulations.gov 
under the docket number found in brackets in the heading of this 
document.

    Dated: March 1, 2024.
Namandj[eacute] N. Bumpus,
Principal Deputy Commissioner.
[FR Doc. 2024-04735 Filed 3-5-24; 8:45 am]
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