FDA Grants Tentative Approval to Dr. Reddy’s Generic Version of Lenacapavir
The FDA’s tentative nod lets Dr. Reddy’s ship a low‑cost generic of the six‑month HIV prevention shot, aiming to broaden reach in poorer nations.
Generic drug approvals are expanding access to breakthrough therapies in low‑ and middle‑income countries.
After months of anticipation, the Food and Drug Administration issued a tentative approval for Dr. Reddy’s Laboratories to manufacture a generic version of lenacapavir, a long‑acting injectable HIV prevention medicine.
Dr. Reddy’s, one of the world’s largest generic drugmakers, intends to start shipping the product next month. The rollout is part of an effort, supported in part by several global health organizations, to make the drug available in lower‑income nations as quickly as possible.
The annual cost per person for the generic will be $40, a price comparable to that of daily oral tablets.
Lenacapavir is an injectable that provides virtually complete protection against HIV with a single dose administered every six months, positioning it as a potentially game‑changing tool in the fight against the virus.
The brand‑name version, sold in the United States as Yetzugo, is marketed by Gilead Sciences and received FDA approval last year.
Expanding affordable access to such innovations could reshape HIV prevention strategies worldwide.
