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# Vanda Tradipitant Scheduling Order Out
- URL: https://www.fdaweb.com/vanda-tradipitant-scheduling-order-out/
- Published: 2025-05-01T12:00:00.000Z
- Updated: 2026-09-14T15:10:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159100

FDA Office of Scientific Integrity director **George Warren** has issued a scheduling order on Vanda Pharmaceuticals’ request for a hearing on CDER’s proposal to refuse to approve the company’s NDA for its gastroparesis drug tradipitant. In the [order](https://downloads.regulations.gov/FDA-2024-N-5933-0046/attachment%5F1.pdf?ref=fdaweb.com), Warren notes that CDER had requested until 9/12 to respond to Vanda’s hearing request, while Vanda had objected, saying FDA should start a hearing no later than 5/7.

Vanda [complained](https://www.fdaweb.com/vanda-criticizes-fda-on-tradipitant-hearing-delay/) in a 4/23 media release that FDA was citing recent staff cuts and the arrival of a new commissioner to justify the delay in scheduling a hearing. Its statement said that commissioner **Martin Makary** “said that any cuts were not to scientists or reviewers, the very individuals who supposedly need more time. This excuse is also suspect because CDER, in prior matters, has requested the same or longer delay to provide hearing recommendations.”

Warren wrote that to expedite the hearing process as much as possible, give CDER and the Office of the Commissioner time to meaningfully evaluate Vanda’s request for a hearing, balance other important public health priorities and ongoing matters, and give Vanda time to respond to CDER’s proposed order, the schedule would be:

- CDER is to respond to Vanda’s request for a hearing on or before 7/18;
- Vanda would have 60 days to respond to any CDER proposed order from the date the order is received;
- no extensions would be granted without a written request based on good cause;
- the Office of the Commissioner will issue a decision on Vanda’s hearing request no later than 60 days after the date the scheduled deadlines expire or the date the Office of the Commissioner receives Vanda’s response to the CDER proposed order, whichever comes first.