Vanda Pharmaceuticals Seeks FDA Commissioner's Review of Controversial Approval of Generic Hetlioz® Versions
Vanda Pharmaceuticals Inc. has requested a review by FDA Commissioner Martin Makary regarding a recent decision by the FDA's Center for Drug Evaluation and Research (CDER) to uphold the approval of two generic versions of Vanda's drug, Hetlioz®. This request follows a decision made by outgoing CDER director Jacqueline Corrigan-Curay, supporting the approval of these generics despite Vanda's concerns about significant flaws in the studies and data presented. Vanda argues that the approval process demonstrated bias towards generic drugs, potentially endangering public safety. The Office of the Commissioner is expected to take two months to decide whether to review the merits of this decision.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vanda Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH56904) on August 21, 2025, and is solely responsible for the information contained therein.
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