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FDA Medical Review – Tepezza (teprotumumab), BLA 761143/S-024
FDA Medical Review – Tepezza (teprotumumab), BLA 761143/S-024
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Original Request: Tepezza (teprotumumab) BLA 761143/S-024; Prior Approval supplemental biologics license application provides for revisions to the INDICATIONS AND USAGE section of the Prescribing Information. Looking for medical review of supplement.
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- 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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