Central African Republic: U.S. FDA Approves First Generic Injectable Lenacapavir for HIV Prevention
[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…
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- FDA Approves First Generic of HIV Prevention Drug, Lenacapavir healthpolicy-watch.news