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FDA Approval – Wegovy (NDA 215256/S-11)
FDA Approval – Wegovy (NDA 215256/S-11)
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Original Request: Summary Basis of Approval (SBA) documents for Wegovy (semaglutide), NDA 215256/S-11, approved to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight, approved March 08, 2024.
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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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