Business · 06/03/2024

FDA Denies Hearing Request for Vanda Pharmaceuticals' Proposal to Refuse HETLIOZ Approval

The FDA has denied a request for a hearing regarding Vanda Pharmaceuticals' proposal to refuse approval of a supplemental new drug application for HETLIOZ (tasimelteon) to treat jet lag disorder.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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