Notice2026-06187
Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules
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 31, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the availability of its decision on a request for a hearing regarding the proposal of FDA's Center for Drug Evaluation and Research (CDER) to refuse to approve a new drug application (NDA) 218489, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules (85 mg) with the proposed indication for "the treatment of [symptoms of] or [nausea in] in gastroparesis" ("symptoms of gastroparesis"). The decision is available in the docket identified by the number in brackets in the heading of this document.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 61 (Tuesday, March 31, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 61 (Tuesday, March 31, 2026)]
[Notices]
[Pages 16007-16008]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5933]
Notice of Decision on a Hearing Request Regarding a Proposal To
Refuse To Approve a New Drug Application for TRADIPITANT Capsules
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of its decision on a request for a hearing regarding the
proposal of FDA's Center for Drug Evaluation and Research (CDER) to
refuse to approve a new drug application (NDA) 218489, submitted by
Vanda Pharmaceuticals, Inc. (Vanda), for TRADIPITANT capsules (85 mg)
with the proposed indication for ``the treatment of [symptoms of] or
[nausea in] in gastroparesis'' (``symptoms of gastroparesis''). The
decision is available in the docket identified by the
[[Page 16008]]
number in brackets in the heading of this document.
DATES: The decision was submitted to the docket on March 26, 2026.
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, Maryland 20993, 240-402-5931.
SUPPLEMENTARY INFORMATION:
I. Background
On September 18, 2023, Vanda submitted NDA 218489 for TRADIPITANT
capsules, 85 milligrams (mg), pursuant to section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) with the
proposed indication for ``the treatment of [symptoms of] or [nausea in]
in gastroparesis'' (``symptoms of gastroparesis''). TRADIPITANT is a
selective neurokinin-1 (NK-1) receptor antagonist.
On September 18, 2024, the Office of Immunology and Inflammation
(OII) in CDER issued a complete response letter (CRL) to Vanda under 21
CFR 314.110, stating that NDA 218489 could not be approved in its
present form. The CRL described specific deficiencies and, where
possible, recommended ways that Vanda might remedy those deficiencies.
On November 25, 2024, Vanda indicated that it wished to receive
approval of its application or a notice of opportunity for a hearing
(NOOH). On January 7, 2025, CDER sent Vanda a NOOH and proposal to
refuse approval of TRADIPITANT to treat gastroparesis, which was then
published in the Federal Register on January 16, 2025 (90 FR 4748).
On January 28, 2025, Vanda provided a notice of participation and
request for a hearing. On March 17, 2025, Vanda submitted documentation
and analysis in support of a request for summary judgment, or
alternatively, a hearing. On July 18, 2025, CDER submitted a Proposed
Order denying Vanda's request for a hearing, and on September 17, 2025,
Vanda submitted its reply to CDER's Proposed Order.
After considering the parties' submissions, on March 26, 2026, FDA
issued a decision regarding Vanda's request for a hearing on CDER's
proposal to refuse to approve NDA 218489.
II. Docket Access
For access to the docket to read the final decision and other
documents pertaining to this matter, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06187 Filed 3-30-26; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on March 31, 2026.
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.