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

 
• By Brenda Sandburg
  
Generate a summary of this article
Listen to this article
Beta

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...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Complete Response Letters

More from Product Reviews

  • data

    New EU Filings

     
    • By Saba Afreen

    <p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>

  • data

    EU CHMP Opinions And MAA Updates

     
    • By Saba Afreen

    <p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

  • EU Biosimilar Filings, Opinions And Approvals

     
    • By Saba Afreen

    <p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>