FDA grants tentative approval for generic HIV prevention shot

The U.S. Food and Drug Administration has granted tentative approval to Dr. Reddy’s Laboratories to make a generic version of lenacapavir, a twice-yearly injectable for HIV prevention. The decision is a step toward expanding access, but it does not mean the medicine is already available through country-level programs. Under a pricing agreement involving Dr. Reddy’s, Unitaid, Wits RHI and the Clinton Health Access Initiative, the generic is set to cost $40 per person per year in 120 countries outside the United States covered by Gilead Sciences’ voluntary licence. The agreement was announced in September 2025 and included financial, technical and regulatory support to speed development and market entry. The FDA’s approval is tentative and was granted through an accelerated pathway, according to Unitaid. Dr. Reddy’s plans to begin shipping the medicine next month, a plan reported by the company, but the sources do not confirm that shipments have begun. The agreement’s price and country coverage likewise describe planned access, not proof that people in those countries can currently obtain the generic. Lenacapavir is administered twice a year and targets HIV’s capsid, the protein...