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...