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FDA Approves Generic Version of HIV-Prevention Drug to Be Sold in Low-Income Countries

The tentative approval could speed access to the twice-yearly HIV prevention shot, which is expected to cost about $40 a year per person.

  • The Food and Drug Administration approved a generic version of the twice-a-year HIV prevention shot for use in 120 low- and middle-income countries, marking a significant step toward expanding global access to lenacapavir.
  • Generic lenacapavir remains unavailable domestically because the brand-name version, Yeztugo, made by Gilead Sciences, is protected by patent; Yeztugo costs $28,218 annually while the generic is expected to cost $40.
  • India-Based Reddy Laboratories developed the generic through an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, aiming to accelerate development and reduce costs.
  • The Food and Drug Administration granted 'tentative' approval, a standard designation for generics while patents exist; Carolyn Amole of the Clinton Health Access Initiative said, 'We could help to scale this to the 20 million people around the world who need PrEP.'
  • According to the WHO, 41 million people worldwide were living with HIV last year and 570,000 died from HIV-related causes; advocates believe this medication will ultimately help drive down new HIV and AIDS cases.
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The FDA approved a generic HIV preventive injection, facilitating its access in low-income countries, reducing transmission risk by 99.9%.Treatment, at $40 a year, will be available in 120 nations, thanks to an agreement between Dr. Reddy's, Unitaid and others, marking a milestone in the fight against HIV.

·Buenos Aires, Argentina
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FDA approves generic version of HIV-prevention drug to be sold in low-income countries

The U.S. FDA has approved a generic version of the world’s only twice-a-year shot to prevent HIV.

·Oklahoma City, United States
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Lean Right

The U.S. Food and Drug Administration (FDA) has approved a generic version of the world's only six-monthly injection to prevent HIV, which means that...

·Madrid, Spain
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Lean Right

The US Food and Drug Administration (FDA) has approved a generic version of an HIV drug that patients only need two doses of a year.

·Oslo, Norway
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Jamaica Gleaner broke the news in Jamaica on Monday, November 2, 2026.
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