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FDA Approval Package for COSENTYX BLA 125504/S-063 – Hidradenitis Suppurativa (Oct 31, 2023)
FDA Approval Package for COSENTYX BLA 125504/S-063 – Hidradenitis Suppurativa (Oct 31, 2023)
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Original Request: Requesting the approval package of the supplemental application for COSENTYX (secukinumab) BLA 125504/S-063 approved on October 31, 2023 for the treatment of adult patients with moderate to severe hidradenitis suppurativa. Please include Multidiscipline Reviews, Statistical Review and Evaluation, Other Reviews, Labeling Reviews, DMEPA Reviews, and Administrative and Correspondence Documents
Tags: Pharma, BLA, 2023
Tags: Pharma, BLA, 2023
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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