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Tag: HETLIOZ

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FDA Must Reconsider Vanda’s Bid for Jet Lag Indication on HETLIOZ

FDA Must Reconsider Vanda’s Bid for Jet Lag Indication on HETLIOZ

A court victory forces the Food and Drug Administration to re-examine rejected application for expanded indication.

  • Vanda Seeks New Markets for Hetlioz Amid Generic Competition

  • Vanda Highlights Q2 Efforts to Expand Hetlioz Amid Regulatory and Market Challenges

  • Vanda’s Hetlioz Faces Dipping Revenue and FDA Challenges in Q1 Report

  • Vanda’s Bid to Expand Hetlioz Use to Insomnia Hits FDA Roadblock

  • FDA Flags Deficiencies in Vanda’s Insomnia sNDA

  • Court Mandates FDA Action on Vanda’s Jet Lag Treatment sNDA

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FDA to Review Vanda’s sNDA for Hetlioz in Insomnia 

FDA to Review Vanda’s sNDA for Hetlioz in Insomnia 

The FDA has accepted a supplemental new drug application from Vanda Pharmaceuticals for Hetlioz (tasimelteon) in insomnia.

  • The Unmet Need for New Insomnia Drugs

    The Unmet Need for New Insomnia Drugs

  • Vanda Preps sNDA for HETLIOZ in Insomnia

    Vanda Preps sNDA for HETLIOZ in Insomnia

  • Some States Extend HETLIOZ Coverage to Patients With Non-24 Who Are Not Totally Blind

    Some States Extend HETLIOZ Coverage to Patients With Non-24 Who Are Not Totally Blind

  • FDA Approves HETLIOZ for Sleep Disturbances in Smith-Magenis Syndrome

    FDA Approves HETLIOZ for Sleep Disturbances in Smith-Magenis Syndrome

  • FDA Grants Priority Review Vanda’s for Melatonin Receptor Agonist HETLIOZ (Tasimelteon) for Smith-Magenis Syndrome

    FDA Grants Priority Review Vanda’s for Melatonin Receptor Agonist HETLIOZ (Tasimelteon) for Smith-Magenis Syndrome

  • Vanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome

    Vanda to Resubmit FDA Application for HETLIOZ for Sleep Disturbance in Patients with Smith-Magenis Syndrome

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