Vanda Pharmaceuticals Inc. announced on October 1, 2025, that it has reached an agreement on a collaborative framework with the U.S. Food and Drug Administration (FDA) for the resolution of certain disputes concerning HETLIOZ (tasimelteon) and tradipitant. This framework aims to streamline the regulatory process for several of Vanda's key assets.
Key features of the agreement include expedited re-reviews by the FDA. The partial clinical hold on tradipitant for the treatment of motion sickness is expected to be re-reviewed by November 26, 2025. Additionally, the supplemental New Drug Application (sNDA) for HETLIOZ for the treatment of jet lag disorder is slated for re-review by January 7, 2026.
The FDA is also expected to complete its review of the New Drug Application (NDA) for tradipitant for the treatment of motion sickness by its existing Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025. This collaborative approach is designed to address ongoing administrative proceedings and litigation, providing a more defined pathway for Vanda's pipeline candidates.
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