Central African Republic: U.S. FDA Approves First Generic Injectable Lenacapavir for HIV Prevention
The U.S. FDA has approved the first generic long-acting injectable for HIV prevention. This approval came 16 months after the original product was approved. A new regulatory strategy allowed for one of the fastest approval timelines for a major HIV innovation. Dr. Reddy's Laboratories developed the product. Financial, technical, and regulatory support was provided by Unitaid, Wits RHI, and the Clinton Health Access Initiative.
[UNITAID] The U.S. Food and Drug Administration (FDA) has approved the first generic long-acting injectable for HIV prevention, just 16 months after the approval of the originator product. A novel regulatory strategy resulted in one of the fastest timelines to approval for a major HIV innovation to date. Developed by Dr. Reddy's Laboratories with financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the product's development and regulatory