FDA Approves First Generic Injectable Lenacapavir for HIV Prevention, Boosting Global Access

The U.S. Food and Drug Administration (FDA) has granted tentative approval for the first generic long-acting injectable lenacapavir, developed by Dr. Reddy's Laboratories, for HIV prevention. This approval, coming just 16 months after the originator product, is expected to make an affordable, twice-yearly HIV prevention option available to people in 120 low- and middle-income countries, with initial supplies anticipated by the end of 2026.