FDA ARCALYST (BLA 125249 – SUPP 49) REVIEW DOCS FOR RECURRENT PERICARDITIS APPROVAL

FDA ARCALYST (BLA 125249 – SUPP 49) REVIEW DOCS FOR RECURRENT PERICARDITIS APPROVAL

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Original Request: All Review Documents for the approval of the following indication for ARCALYST (rilonacept) (BLA 125249 – Supplement 49) approved on March 18, 2021: Treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years of age and older.
Tags: Pharma, BLA, 2021
  • 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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