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    FDA Approval Files for Elrexfio, Vonjo, Galafold, Tafinlar

    FDA Approval Files for Elrexfio, Vonjo, Galafold, Tafinlar

    $69.00 USD
    $69.00 USD
    Sale Sold out
    Original Request: -All public portions of the FDA’s approval file for the following four drugs, including but not limited to the applicant’s initial application, revised filings, as well as the agency’s reports, research, evaluations and recommendations by its Center for Drug Evaluation and Research: elranatamab-bcmm (Elrexfio, Pfizer); pacritinib (Vonjo, CTI BioPharma Corp.); migalastat (Galafold, Amicus Therapeutics); dabrafenib (Tafinlar, Novartis)
    Tags: Pharma, NDA, 2024
    • 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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