FDA Approves Truvada For PrEP With Bolstered Labeling But No Restricted Distribution

Concerned about impeding drug access for HIV treatment, the agency declined to restrict prescribing of Gilead’s antiretroviral for pre-exposure prophylaxis to documented evidence of a negative HIV test, although the label’s newly revised boxed warning highlights the need for confirmation of HIV-negative status.

FDA approved Gilead Sciences Inc.’s HIV drug Truvada (emtricitabine/tenofovir) for pre-exposure prophylaxis (PrEP) with stronger label warnings and directions for use than originally proposed, but without a restricted distribution system that had been urged by some of the agency’s outside experts.

On July 16, FDA approved the nucleoside/nucleotide reverse transcriptase inhibitor, in combination with safer sex practices, for PrEP to reduce...

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