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Nov 2, 2026

FDA approves generic version of HIV-prevention shot lenacapavir

The U.S. Food and Drug Administration has approved a generic version of the world's only twice-a-year shot to prevent HIV, a significant step toward making the drug available inexpensively and more quickly in low-income countries.

Nov 2, 2026·2 sources

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Top claims

▪Lenacapavir proved more than 99.9% effective in large clinical trials and nearly eliminated new HIV infections among high-risk individuals
▪Generic lenacapavir manufactured by Dr. Reddy's Laboratories will be priced at $40 per person per year in 120 low- and middle-income countries under a September 2025 pricing agreement brokered by Unitaid
▪The U.S. FDA approved Dr. Reddy's generic lenacapavir under an accelerated pathway and a longstanding practice designed to evaluate HIV drugs provided to foreign countries by the U.S. government

Topics

Accelerated approval pathways Preventive medicine Drug Policy, Pricing & Approval Infectious Disease and Outbreaks Generic drugs FDA drug approval Drug pricing Global health

Related entities

Sub-Saharan Africa