Business · 03/06/2026Updated: 10/17/2026 · 1 min read

Vanda Pharmaceuticals to Face FDA Hearing on Proposed Refusal of HETLIOZ Supplemental Approval

Summary

The FDA is holding a public hearing on Vanda Pharmaceuticals' proposal to refuse approval of a supplemental new drug application for HETLIOZ (tasimelteon) to treat jet lag disorder, following a timely request from the company.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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