Vanda seeks FDA commissioner review of hetlioz generic approvals

 Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a $267 million market cap pharmaceutical company with impressive gross profit margins of 94.4%, has requested that FDA Commissioner Martin Makary review a recent decision upholding the approval of two generic versions of its drug Hetlioz, according to a company press release issued Thursday.

The pharmaceutical company is challenging a July 2025 ruling by Jacqueline Corrigan-Curay, the departing director of the FDA’s Center for Drug Evaluation and Research (CDER), who upheld the Office of Generic Drugs’ earlier decision to approve the generic versions.

Vanda originally filed citizen petitions in 2023 contesting the approvals, arguing there were significant flaws in the studies and data presented by the generic manufacturers. The company claims the FDA accepted bioequivalence studies that included only Indian male subjects for establishing use in the general U.S. population.

The company also expressed concerns about data inconsistencies in measuring drug exposure levels, noting that one generic version showed exposure levels more than double those Vanda has obtained for Hetlioz.

According to Vanda, FDA officials have indicated it could take two months for the Office of the Commissioner to decide whether to review the merits of this decision.

Hetlioz is a prescription medication developed by Vanda Pharmaceuticals. The company’s challenge comes amid its concerns about what it describes as "the FDA’s unacceptable culture of bias toward approving generic drugs regardless of whether they meet the requisite legal and evidentiary standards."

https://www.investing.com/news/company-news/vanda-seeks-fda-commissioner-review-of-hetlioz-generic-approvals-93CH-4205655