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FDA Revises Letter of Authorization for Paxlovid EUA
- By: admin
- On: 02/13/2024 13:18:01
- In: KPhA Updates
FDA Revises Letter of Authorization for Paxlovid EUA
On January 29, 2024, the FDA revised the Paxlovid EUA, stating that the EUA-labeled Paxlovid distributed by the US government will only remain authorized through March 8, 2024. On January 31, 2024, HHS-ASPR issued a COVID-19 Therapeutics Stakeholder letter via email to all Paxlovid providers with instructions for return of product. Highlights of both letters can be found below.
- EUA-labeled Paxlovid distributed by the U.S. government (USG) will remain authorized for use only through March 8, 2024
- The deadline for the USG to receive credit for the return of EUA-labeled Paxlovid has been extended from January 31, 2024, to February 29, 2024. Product received by February 29 will be accepted for credit to the federal inventory
- For information on returning EUA labeled Paxlovid with expiration December 2023 and on, visit www.PaxlovidEUAreturns.com.
- Information on PAXCCESS Patient Support Program can be found at PAXCESSPatientPortal.com or call 1-877-C19-PACK (1-877-219-7225).
Click the following links for more information:
HHS ASPR COVID-19 Therapeutics Stakeholder Letter
FDA Letter Revising Paxlovid
HHS ASPR COVID-19 Therapeutics Stakeholder Letter
FDA Letter Revising Paxlovid