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FDA Superseding Exclusivity Summary – Tyvaso DPI (NDA 214324)
FDA Superseding Exclusivity Summary – Tyvaso DPI (NDA 214324)
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Original Request: The FDA’s Superseding Exclusivity Summary for Tyvaso DPI (treprostinil) inhalation powder (NDA 214324). The Superseding Exclusivity Summary was completed by the Division of Cardiology and Nephrology within the Center for Drug Evaluation and Research, on or around August 14, 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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