FDA grants tentative approval for generic HIV prevention shot, boosting access in low-income nations

After months of anticipation, the U.S. Food and Drug Administration issued a tentative approval for Dr. Reddy’s Laboratories to produce a generic version of lenacapavir, the long‑acting injectable used to prevent HIV infection.

The company plans to begin shipping the medicine next month, targeting low‑ and middle‑income countries. The generic is priced at about $40 per person per year, a cost comparable to daily oral tablets.

Lenacapavir is praised for delivering almost complete protection against HIV with a single injection every six months, positioning it as a potentially transformative tool in the fight against the virus.

The approval aligns with efforts by global health groups to make the preventive drug widely available, and could influence pricing and market dynamics for HIV prevention therapies.