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    Hetlioz

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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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    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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    Vanda takes issue with FDA's relay of deficiencies for new Hetlioz indication
    Vanda takes issue with FDA's relay of deficiencies for new Hetlioz indication

    05 Feb 2024

    // ENDPTS

    https://endpts.com/vanda-takes-issue-with-fdas-relay-of-deficiencies-for-new-hetlioz-indication/

    ENDPTS
    05 Feb 2024
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    Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Appeal
    Vanda Pharmaceuticals Responds to Ruling in HETLIOZ® ANDA Appeal

    10 May 2023

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-responds-to-ruling-in-hetlioz-anda-appeal-301821307.html

    PR NEWSWIRE
    10 May 2023
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