FDA Approves Two HIV Drugs for Sale Outside the U.S.
One is a triple-dose combination tablet for children
TUESDAY, Aug. 14 (HealthDay News) -- Two medications targeting HIV infection, one of them for children, have gained tentative approval by the U.S. Food and Drug Administration for sale outside the United States.
A triple-dose tablet that combines lamivudine, stavudine and nevirapine is designed for children under the age of 12. The tablet, which is to be taken twice daily, can be dissolved in water. The combination tablet is a complete HIV regimen that can be easily stored, distributed and administered, according to an FDA statement.
The second medication to gain tentative FDA approval is nevirapine, which is indicated for use with other antiretroviral agents for treatment of HIV-1 infection.
Both medications are part of the President's Emergency Plan for AIDS Relief (PEPFAR). Their tentative approval means they have been evaluated by the FDA for safety and efficacy, despite the fact that patent or exclusivity restrictions prohibit their sale in the United States. The PEPFAR program collaborates with the World Health Organization's Prequalification Program, which helps guide the purchase of drug products by countries with developing economies.