FDA refuses TRADIPITANT Capsules approval, hearing denied

Content

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

     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 https://www.regulations.gov 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

Download File

Download