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    Tasimelteon

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    NEWS #PharmaBuzz

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    Vanda Pharma Publishes Study On Hetlioz® For Insomnia In PLOS One
    Vanda Pharma Publishes Study On Hetlioz® For Insomnia In PLOS One

    25 Sep 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-the-publication-in-plos-one-of-an-article-titled-melatonin-agonist-tasimelteon-hetlioz-improves-sleep-in-patients-with-primary-insomnia-a-multicenter-randomized-double-blind-placebo-controll-302567056.html

    PR NEWSWIRE
    25 Sep 2025
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    Vanda Seek FDA Review of CDER Director’s Hetlioz Generic Approval
    Vanda Seek FDA Review of CDER Director’s Hetlioz Generic Approval

    21 Aug 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/vanda-seeks-fda-commissioner-review-of-outgoing-cder-directors-decision-to-uphold-approval-of-two-generic-versions-of-hetlioz-302536237.html

    PR NEWSWIRE
    21 Aug 2025
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    Federal Appeals Court overturns FDA, approves Vanda's Hetlioz
    Federal Appeals Court overturns FDA, approves Vanda's Hetlioz

    18 Aug 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/in-a-major-win-for-vanda-a-federal-appeals-court-overturns-fdas-order-denying-approval-of-hetlioz-for-the-treatment-of-jet-lag-disorder-302531842.html

    PR NEWSWIRE
    18 Aug 2025
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    Vanda Sues Fda For Right To Promote Off-Label Drug Use
    Vanda Sues Fda For Right To Promote Off-Label Drug Use

    14 Apr 2025

    // FIERCE PHARMA

    https://www.fiercepharma.com/marketing/after-hetliozs-rejection-jet-lag-vanda-sues-fda-right-promote-label-usage

    FIERCE PHARMA
    14 Apr 2025
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    FDA Confirms Para IV Patent for Tasimelteon (Hetlioz LQ) Oral Suspension
    FDA Confirms Para IV Patent for Tasimelteon (Hetlioz LQ) Oral Suspension

    17 May 2024

    // FDA

    https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-for-tasimelteon-hetlioz-lq-oral-suspension-24597.pdf

    FDA
    17 May 2024
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    FDA denies hearing to Vanda on jet lag indication for sleep disorder drug
    FDA denies hearing to Vanda on jet lag indication for sleep disorder drug

    06 Mar 2024

    // ENDPTS

    https://endpts.com/fda-denies-hearing-to-vanda-on-jet-lag-indication-for-sleep-disorder-drug/

    ENDPTS
    06 Mar 2024
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