Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act ...
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and
( printed page 67836)
Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that Bixlenvo (bictegravir and lenacapavir), tablets, approved August 27, 2026, meet the redemption criteria.
FOR FURTHER INFORMATION CONTACT:
Andrea Gormley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3751, email:
Andrea.Vincent@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Under section 565A of the FD&C Act (21 U.S.C. 360bbb-4a), which was added by section 3086 of the Cures Act (Pub. L. 114-255), FDA will report the issuance of material threat MCM priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the application for, Bixlenvo (bictegravir and lenacapavir), tablets approved August 27, 2026, meets the redemption criteria.
Use this for formal legal and research references to the published document.
91 FR 67835
Web Citation
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Use this when citing the archival web version of the document.
“Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir),” thefederalregister.org (October 28, 2026), https://thefederalregister.org/documents/2026-21909/notice-of-approval-of-product-under-voucher-material-threat-medical-countermeasure-mcm-priority-review-voucher-bixlenvo-.
21 U.S.C. 360bbb-4a
www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv
www.accessdata.fda.gov/scripts/cder/daf/