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# FDA, Vanda Agree on Dispute Actions
- URL: https://www.fdaweb.com/fda-vanda-agree-on-dispute-actions/
- Published: 2025-10-02T12:00:00.000Z
- Updated: 2026-09-14T15:23:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159977

FDA and Vanda Pharmaceuticals have agreed to a framework for resolving their ongoing disputes about the company’s sleep-wake cycle drug Hetlioz (tasimelteon) and its gastroparesis drug tradipitant. A Vanda [statement](https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-collaborative-framework-for-resolution-of-disputes-with-the-us-food-and-drug-administration-302573077.html?ref=fdaweb.com) lists these features of the agreement:

- FDA will conduct an expedited re-review of the partial clinical hold preventing long-term clinical studies of tradipitant to treat motion sickness by 11/26 and will continue its review of the company’s NDA for this indication with the current PDUFA action date of 12/30;
- FDA will conduct an expedited re-review of Vanda’s sNDA for Hetlioz to treat jet lag disorder by 1/7/2026, including the consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder;
- FDA and Vanda will seek a temporary pause of the ongoing administrative proceedings before the FDA commissioner on Vanda’s NDA for tradipitant to treat gastroparesis until 1/7/2026;
- FDA and Vanda have sought a pause in the company’s suit challenging FDA’s practice of taking up to 12 months, rather than the statutory 180 days, to decide NDAs;
- Vanda will dismiss its suit challenging the FDA partial clinical hold preventing long-term studies of tradipitant to treat motion sickness; and
- Vanda will dismiss its suit on its request to provide information to prescribers and patients about Hetlioz’ efficacy in jet lag disorder.