Tentative approval of two antiretroviral drugs under the US President's Emergency Plan for AIDS Relief (PEPFAR) was granted Monday by the US Food and Drug Administration.
PEPFAR supports treatment for people in 15 countries in sub-Saharan Africa, Asia and the Caribbean.
The two newly approved drugs are nevirapine tablets, indicated for use with other antiretroviral drugs for the treatment of HIV-1 infection; and the paediatric triple fixed dose combination tablet of lamivudine, stavudine and nevirapine, the first fixed dose anti-HIV product designed to treat children under age 12.
These are the 50th and 51st antiretroviral drugs tentatively approved under PEPFAR. These two new drugs and 46 other generic drugs (or drug combinations) have been evaluated by the FDA under PEPFAR, but are not available for sale in the United States because of patent or other kinds of marketing protections.
Three other drugs evaluated by the FDA under this programme are for sale in the United States. All 51 drugs approved by the FDA under PEPFAR can be purchased outside of the United States by PEPFAR partners using US taxpayer dollars. – (HealthDayNews)