Vanda Pharmaceuticals (Nasdaq: VNDA) has reached a collaborative framework with the FDA to resolve multiple regulatory disputes regarding HETLIOZ® and tradipitant. The agreement includes expedited reviews of several key applications: the partial clinical hold on tradipitant for motion sickness by November 26, 2025, the NDA review with a PDUFA date of December 30, 2025, and the sNDA for HETLIOZ® for jet lag disorder by January 7, 2026.
As part of the agreement, Vanda will dismiss multiple lawsuits against the FDA, including challenges to the clinical hold on tradipitant and HETLIOZ® efficacy information sharing. The framework also includes temporary pauses in various administrative proceedings and legal actions to facilitate the resolution process.
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