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    FDA sBLA Multidisciplinary Review for Dupixent (Prurigo Nodularis) Approval 09/28/2022

    FDA sBLA Multidisciplinary Review for Dupixent (Prurigo Nodularis) Approval 09/28/2022

    $69.00 USD
    $69.00 USD
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    Original Request: Multidisciplinary review for the sBLA approval of Dupixent (dupilumab) injection, for the treatment of adult patients with prurigo nodularis. Approval date, Sept 28, 2022. Document must include clinical, nonclinical, clinical pharmacology, and biostatistics reviews.
    Tags: Pharma, BLS, 2022
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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