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    • ADMINISTRATION OF FDC ACT—NOTICES: CDER proposes to refuse to approve a new drug application supplement for HETLIOZ
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: CDER proposes to refuse to approve a new drug application supplement for HETLIOZ, (Jun 11, 2024)

    Organizations Mentioned:Vanda Pharmaceuticals, Inc.

    By WK Editorial Staff

    The Director of CDER is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc.

    The Director of the Center for Drug Evaluation and Research (CDER) at the FDA is proposing to refuse to approve ...

    By WK Editorial Staff

    The Director of CDER is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc.

    The Director of the Center for Drug Evaluation and Research (CDER) at the FDA is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc., for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. The notice summarizes the grounds for the Center Director’s proposal and offers Vanda an opportunity to request a hearing on the matter (Notice, 89 Fed. Reg. 48647 (June 7, 2024)).

    Dates. Either electronic or written requests for a hearing must be submitted by July 8, 2024; submit data, information, and analyses in support of the hearing and any other comments by August 6, 2024.

    FederalRegisterIssuances: Notices FDCActNews DrugBiologicNews PrescriptionDrugNews

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