The drug, among a class called integrase strand transfer inhibitors, interferes with an enzyme that HIV needs to multiply. It's been approved in combination with other antiretroviral drugs and for people aged 12 and older who weigh at least 40 kilograms (approximately 88 pounds), the FDA said in a news release.
The drug's safety and effectiveness were evaluated in clinical studies involving more than 2,500 adults and children, the FDA said. The most common side effects included difficulty sleeping, headache and more serious problems including allergic-like reactions and abnormal liver function in people who had hepatitis B or C.
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