Hetlioz®

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Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®
Prnewswire· 2025-08-21 20:40
WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review the decision made by Jacqueline Corrigan-Curay, the departing director of the FDA's Center for Drug Evaluation and Research (CDER), days before her retirement that upholds an Office of Generic Drugs decision to approve two generic versions of Hetlioz®.In 2023, Vanda filed citizen petitions challe ...