Vanda May Go Another Round With US FDA Over Hetlioz Jet Lag Indication

Agency offers Vanda chance to request a hearing over its plan to refuse to approve its supplemental new drug application. Such a hearing seems unlikely given FDA’s rejection of past requests and Vanda’s track record with the agency.

Boxing — Vanda ready to fight FDA over its intent to refuse to approve Hetlioz for treatment of jet lag disorder • Source: Shutterstock

The US Food and Drug Administration has been disinclined to reconsider its decisions to reject new drug applications. But the agency is once again invoking a rarely used procedure in offering Vanda Pharmaceuticals, Inc. the opportunity to request a hearing over its proposal to refuse to approve the company’s supplemental new drug application for Hetlioz (tasimelteon) for treatment of jet lag disorder.

The FDA announced in a notice to be published in the 11 October Federal Register that it is proposing...