05:24 PM EDT, 08/21/2025 (MT Newswires) -- Vanda Pharmaceuticals ( VNDA ) said late Thursday it has asked the US Food and Drug Administration commissioner Martin Makary to review the decision by the outgoing director of Center for Drug Evaluation and Research, Jacqueline Corrigan-Curay, that upholds approval of two generic versions of the Hetlioz drug.

Hetlioz is used to treat Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in Smith-Magenis Syndrome.

In 2023, Vanda filed citizen petitions challenging the FDA's decision for the generic versions of the drug, citing flaws in the studies and data presented, according to a statement.

Corrigan-Curay issued a decision in July siding with the prior FDA decision to approve the generic versions, the company said.

The company added that the FDA bureaucrats suggested that the commissioner's office will take two months to decide whether to review the merits of this decision.