Vanda Pharmaceuticals Requests FDA Review of Hetlioz Generics Approval

Vanda Pharmaceuticals has requested FDA Commissioner Marty Makary to review the approval of two generics of Hetlioz (tasimelteon). The generics were previously upheld by the retired director of the Center for Drug Evaluation and Research. The move comes after generic tasimelteon became available.

Vanda Pharmaceuticals (NASDAQ: VNDA) has formally requested U.S. FDA Commissioner Marty Makary to review the approval of two generic versions of Hetlioz (tasimelteon). The request comes after the retired director of the Center for Drug Evaluation and Research (CDER) upheld the approvals, despite a 2022 court ruling that found some of Vanda's patents for Hetlioz to be invalid. The U.S. Supreme Court declined to hear Vanda's appeal in 2024 [1].

The generics, produced by Teva Pharmaceutical (TEVA) and Apotex, were approved despite concerns raised by Vanda. The company argues that the approval process involved small studies with Indian male subjects, which may not accurately reflect the general US population. Vanda contends that this approach undermines the integrity of the generic drug approval process [2].

Vanda's challenge is part of a broader legal battle that began in 2023 when the company submitted a citizen petition challenging the generic approvals. In August 2025, a Federal Appeals Court overturned an FDA order denying approval of Hetlioz for the treatment of jet lag disorder, marking a significant victory for Vanda [2].

The request to Commissioner Makary is seen as a strategic move by Vanda to address perceived flaws in the approval process. The company hopes that a review by the FDA Commissioner will lead to a more rigorous evaluation of the generic approvals.

References:
[1] https://www.ainvest.com/news/vanda-pharmaceuticals-requests-fda-review-hetlioz-generics-approval-2508/
[2] https://www.biospace.com/press-releases/vanda-seeks-fda-commissioner-review-of-outgoing-cder-directors-decision-to-uphold-approval-of-two-generic-versions-of-hetlioz