Notice2024-04735
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 45 (Wednesday, March 6, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Page 16001]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04735]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov/docket/FDA-2022-N-2390">https://www.regulations.gov/docket/FDA-2022-N-2390</a>. The final
decision and other documents pertaining to the refusal to approve
HETLIOZ (sNDA 205677-004) are available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on March 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.