US FDA Authorizes First Generic Long-Acting Injectable for HIV Prevention

The U.S. Food and Drug Administration (FDA) has approved the first generic long-acting injectable, Lenacapavir, for HIV prevention. This rapid regulatory action occurred just 16 months after the originator product's approval, representing one of the fastest timelines for a major HIV innovation. This development, supported by Unitaid, Wits RHI, and CHAI, aims to significantly improve access to critical HIV prevention methods globally.