Vanda Pharmaceuticals, FDA agree to resolve disputes on Hetlioz and tradipitant

Vanda Pharmaceuticals (VNDA) announced that it has agreed on a collaborative framework with the FDA for the resolution of certain disputes regarding Hetlioz and tradipitant. The FDA will conduct an expedited re-review of the partial clinical hold preventing long term clinical studies of tradipitant for the treatment of motion sickness by November 26. The FDA will continue its review of Vanda’s new drug application for this indication, with the existing Prescription Drug User Fee Act target action date of December 30. The FDA will conduct an expedited re-review of Vanda’s supplemental new drug application for Hetlioz for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. During the re-review, Vanda and the FDA will seek a temporary pause of the Part 12 proceedings that result from the D.C. Circuit’s recent decision in Vanda Pharmaceuticals v. FDA, No. 24-1049. The FDA and Vanda will seek a temporary pause of the ongoing administrative proceedings before the FDA Commissioner for Vanda’s NDA for tradipitant for the treatment of gastroparesis, until January 7, 2026. Vanda and the FDA have sought a pause in Vanda’s lawsuit challenging the FDA’s practice of taking up to 12 months-rather than the statutory 180 days-to decide new drug applications, Vanda Pharms. Inc. v. FDA, Nos. 24-cv-351 and 25-cv-536. Vanda will dismiss its lawsuit challenging the FDA’s partial clinical hold preventing long term studies of tradipitant for the treatment of motion sickness, Linn v. FDA, No. 2:25-cv-32. Vanda will dismiss its lawsuit regarding Vanda’s request to provide information to prescribers and patients regarding the efficacy of Hetlioz in jet lag disorder, Vanda Pharms. Inc. v. FDA, No. 4:25-cv-1648.