Vanda Pharmaceuticals Seeks FDA Commissioner's Review of Controversial Approval of Generic Hetlioz® Versions
Reuters
Aug 22
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.
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