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# Vanda Can Seek Tradipitant Hearing: FDA Notice
- URL: https://www.fdaweb.com/vanda-can-seek-tradipitant-hearing-fda-notice/
- Published: 2025-01-15T12:00:00.000Z
- Updated: 2026-09-14T14:50:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158492

FDA has published a *Federal Register* notice indicating its intention to deny the Vanda Pharmaceuticals NDA for tradipitant capsules, 85 mg, in its present form and offering the company the opportunity to request a hearing with the commissioner. The [notice](https://public-inspection.federalregister.gov/2025-01027.pdf?ref=fdaweb.com) says the NDA seeks an indication for “the treatment of \[symptoms of\] or \[nausea in\] gastroparesis.”

The CDER Office of Immunology and Inflammation issued a 9/18/2024 complete response letter to Vanda saying that the NDA could not be approved in its present form because the application did not provide substantial evidence of effectiveness for the drug and did not demonstrate that it is safe for the proposed conditions of use. The letter described the specific deficiencies that led to CDER’s determination and, where possible, recommended ways that Vanda might remedy the deficiencies.

The notice says that on 11/25/2024, Vanda indicated it wanted to receive approval of its NDA or a notice of an opportunity for a hearing. It says that if Vanda chooses to seek a hearing, it must submit the studies, data, information, and analyses relied upon to justify a hearing. “The commissioner will grant a hearing if there exists a genuine and substantial issue of fact or if the commissioner concludes that a hearing would otherwise be in the public interest,” FDA says.