JOIN USDeveloped by Johnson & Johnson, TMC278, also known as rilpivirine, is especially for patients who have never begun HIV treatment, the FDA said in a statement.
J&J will market the drug under the name Edurant.
The new medication was approved after two clinical trials were carried out with 1,368 adults who had received no previous anti-HIV treatment.
During the trials, the patients were randomly assigned treatments with rilpivirine or efavirenz (sold by Bristol-Myers Squibb Co. as Sustiva), and with other pharmaceuticals.
In the clinical trials, 83 percent of those who received rilpivirine suppressed the reproduction of the virus at undetectable levels, while the same occurred with 80 percent of those who received efavirenz.
The most common side effects among patients who took Edurant included depression, insomnia, headaches and rashes.
The FDA warned that Edurant does not cure HIV infections and that patients must have continuous treatment with the new once-a-day pill to control infection and reduce the tendency to contract illnesses caused by the virus.