Truvada can be used by those at high risk of infection and anyone who may engage in sexual activity with HIV-infected partners, said the Food and Drug Administration (FDA).
The move follows a 19-3 vote in favour by an advisory group of health experts.
Some health workers and groups active in the HIV community opposed a green light for the once-daily pill.
There have been concerns the circulation of such a drug could engender a false sense of security. There have also been fears that a drug-resistant strain of HIV could develop.
In a statement, the FDA stressed that the drug should be used as part of a "comprehensive HIV prevention plan", including condom use and regular HIV testing.
Truvada, made by California-based Gilead Sciences, is already approved by the FDA for people who are HIV-positive, and is taken along with existing anti-retroviral drugs.
Studies from 2010 showed that Truvada reduced the risk of HIV in healthy gay men - and among HIV-negative heterosexual partners of HIV-positive people - by between 44% and 73%.
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