By Julian Hattem - 08/12/13 09:33 PM EDT
The pill is taken daily in combination with others and can be prescribed to patients who have never taken therapy before, as well as those that have. It is approved for people ages 12 and older.
“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, head of the FDA’s antimicrobial drugs office, in a statement. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
Common side effects of Tivicay include insomnia and headaches.
There are about 1.1 million people in the U.S. with HIV, though about 18 percent do not know they are infected, according to the Centers for Disease Control and Prevention. About 15,500 died in 2010.
There is no cure for HIV, but the FDA has approved more than 35 antiretroviral drugs that can treat it. Drugs are often taken in combination.
In June, the FDA released draft guidance intended to make it easier for pharmaceutical companies to develop new HIV drugs.