Vanda Pharmaceuticals Announces Collaborative Framework for Resolution of Disputes with the U.S. Food and Drug Administration

Core Viewpoint - Vanda Pharmaceuticals has established a collaborative framework with the FDA to resolve disputes regarding its drugs HETLIOZ and tradipitant, which includes expedited reviews and temporary pauses in ongoing litigation [1][3]. Summary by Relevant Sections Agreement with FDA - Vanda Pharmaceuticals has agreed on a collaborative framework with the FDA to address disputes related to HETLIOZ (tasimelteon) and tradipitant [1]. - The FDA will conduct an expedited re-review of the partial clinical hold on tradipitant for motion sickness by November 26, 2025, and continue its review of the New Drug Application (NDA) with a target action date of December 30, 2025 [3]. Drug Applications and Reviews - The FDA will also expedite the re-review of Vanda's supplemental NDA for HETLIOZ for jet lag disorder by January 7, 2026, focusing on sleep-related aspects [3]. - Vanda and the FDA will seek a temporary pause in ongoing administrative proceedings related to tradipitant for gastroparesis until January 7, 2026 [3]. Legal Actions - Vanda will dismiss its lawsuits challenging the FDA's practices regarding drug application timelines and the partial clinical hold on tradipitant [3].