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HIV: Dr. Reddy’s injectable generic receives tentative approval

Indian manufacturer Dr. Reddy’s announced tentative FDA approval for its injectable lenacapavir for HIV prevention on 2 November 2026.

Given twice yearly, the product is planned at $40 per person annually in the 120 countries covered by Gilead’s licence. Partners expect initial supplies before the end of 2026 and broader availability in 2027.

The decision does not permit US sales, where the original medicine remains protected. National authorisations and procurement will determine actual access.

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