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

 
• By Brenda Sandburg

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 to refuse the application because there is a lack of substantial evidence that Hetlioz is effective for the indication

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