Business · 07/03/2025Updated: 10/17/2026 · 1 min read

FDA Denies Hearing Request for HETLIOZ Supplemental New Drug Application

The FDA has denied a request for a hearing regarding a proposal to refuse approval of a supplemental new drug application for HETLIOZ (tasimelteon) for treating insomnia, submitted by Vanda Pharmaceuticals, Inc. The decision is available on the FDA's website.

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

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