Vanda Pharmaceuticals Inc. announced on August 21, 2025, that it has formally requested U.S. Food and Drug Administration (FDA) Commissioner Martin Makary to review a decision upholding the approval of two generic versions of HETLIOZ. This decision was made by Jacqueline Corrigan-Curay, the departing director of the FDA's Center for Drug Evaluation and Research (CDER), just days before her retirement.
Vanda had filed citizen petitions in 2023, challenging the FDA's approval of these generic versions due to alleged significant flaws in the studies and data presented. The company argued that the CDER director's decision accepted that generic manufacturers could use small studies with only Indian male subjects to establish bioequivalence for the general U.S. population.
Vanda also highlighted that one generic version showed exposure levels more than double those obtained for HETLIOZ, which was accepted by the FDA. Vanda views this as reflecting an "unacceptable culture of bias toward approving generic drugs" and is urging Commissioner Makary to ensure the rule of law returns to the FDA, criticizing the agency's suggestion of a two-month delay for the Commissioner's office to decide on reviewing the merits of the decision.
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