HIV is the virus that causes AIDS. Edurant, a so-called non-nucleoside reverse transcriptase inhibitor (NNRTI), blocks the virus's ability to reproduce itself. The pill is taken once daily with food, the FDA said in a news release.
Edurant was evaluated in a pair of 48-week studies involving 1,368 adults infected with HIV. Compared to another NNRTI, efavirenz, Edurant was as effective in lowering amounts of the virus in a person's blood, the agency said.
The most common adverse reactions reported were depression, insomnia, headache and rash.
Since Edurant does not reverse HIV infection, people must continue taking the drug, in combination with other anti-HIV medications, to prevent HIV-related illness, the FDA said.
Edurant is produced by Tibotec Therapeutics, based in Raritan, N.J.
Visit aids.gov to learn more about HIV/AIDS.