The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Department of Health and Human Services (HHS) today marked today marked the recent approval of the 100th antiretroviral drug in association with the President’s Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.
The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Department’s Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.
To date, more than 100 products that have been assessed by the FDA and either fully or tentatively approved in association with the PEPFAR program. Of these, 29 have been new products and 71 have been generic copies of previously authorized antiretroviral products in the United States. Twenty-two of these new products are new combinations or regimens that have not previously been authorized in the United States. In addition, there are seven new pediatric products considered innovative for patients in developing economies.
For more information, please visit: PEPFAR
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