Vanda asks FDA's Makary to review approval of Hetlioz generics

Noam Galai

* Vanda Pharmaceuticals (NASDAQ:VNDA [https://seekingalpha.com/symbol/VNDA]) has formally asked U.S. FDA Commissioner Marty Makary to review the recently retired director of the Center for Drug Evaluation and Research's decision to uphold the approval of two generics of Hetlioz (tasimelteon).
* Generic tasimelteon is available from Teva Pharmaceutical (TEVA [https://seekingalpha.com/symbol/TEVA]) and Apotex.
* Vanda submitted a citizen petition in 2023 challenging the generic approvals, but they were rebuffed. A court in 2022 held that some of Vanda's patents for Hetlioz were invalid. In 2024, the U.S. Supreme Court declined [https://seekingalpha.com/news/4091961-us-supreme-court-reportedly-declines-to-hear-vanda-patent-case] to hear Vanda's appeal.
* Former acting CDER Director Jacqueline Corrigan-Curay, just before her retirement in July, agreed with an earlier decision that the generic approvals were legitimate.
* Vanda claims [https://seekingalpha.com/pr/20208769-vanda-seeks-fda-commissioner-review-of-outgoing-cder-directors-decision-to-uphold-approval-of] that Corrigan-Curay's decision means "that generic drug manufacturers need only conduct small studies that include only Indian male subjects to establish bioequivalence for use in the general US population."

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