FDA Approval – Mounjaro (tirzepatide) S-002 Human Factors

FDA Approval – Mounjaro (tirzepatide) S-002 Human Factors

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Original Request: I am requesting the FDA Summary Basis of Approval documents for Mounjaro (tirzepatide) for prior approval supplement (S-002), approved on 7/28/2023. In particular, I am interested in any review documents related to human factors testing of the tirzepatide vial and syringe.
  • 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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