The Food and Drug Administration has given tentative approval to Dr. Reddy's Laboratories to make a generic version of the HIV prevention medicine lenacapavir, STAT reports. STAT calls it a key step for access in dozens of poorer countries.

The approval was granted under the President's Emergency Plan for AIDS Relief, or PEPFAR, The Hindu reports. Dr. Reddy's announced it on Monday.

The shot offers almost full protection against HIV with one dose every six months, STAT reports. The brand-name version is sold by Gilead Sciences. The FDA approved it last year, STAT says.

Dr. Reddy's plans to start shipping the medicine next month, STAT reports. The annual cost per person will be $40, comparable to daily tablets, STAT says.

First supplies are expected to reach people by December, with a wider rollout across eligible countries expected in 2027, the company said, according to The Hindu.

Gilead gave Dr. Reddy's a licence to make the drug in October 2024, The Hindu reports. Health groups such as Unitaid later agreed to back the work.

"Getting a generic approved just 16 months after the originator shows what's possible when we prioritise access from the start," said Neil Buddy Shah, the chief executive of the Clinton Health Access Initiative, according to The Hindu.

The company said the next steps include review by the World Health Organization and by national regulators, The Hindu reports.

What we know: The FDA has given tentative approval to the generic shot.
What we don't know: How quickly national regulators will approve it for use.