FDA Tentatively Approves Generic HIV Prevention Shot at $40/Year

Dr. Reddy's Laboratories receives tentative FDA approval for generic lenacapavir, a twice-yearly injectable PrEP offering virtually complete protection.

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FDA OKs generic HIV prevention shot, widening access for lower-income countries

TLDR

The long-acting formulation (two shots yearly) offers virtually complete protection against HIV. Dr. Reddy's plans to start shipping the tentatively approved generic in December 2026. Its $40 annual cost will be comparable to daily tablets, a potential boost for access in low- and middle-income countries.

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