FDA approves 100th antiretroviral drug for PEPFAR

WASHINGTON The Food and Drug Administration has approved the 100th antiretroviral drug under the President's Emergency Plan for AIDS Relief, the agency announced Tuesday.

“This milestone exemplifies the dedication, caring and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS,” Dept. of Health and Human Services secretary Kathleen Sebelius said in a statement.

The PEPFAR program is an effort between the FDA and other agencies in HHS, the Department of State, the Department of Defense and overseas governments designed to prevent, treat and care for people with HIV and AIDS. Of the more than 100 products that have received either full or tentative FDA approval under the program, 29 are branded drugs and 71 are generics.

“As we recognize the 100th product authorized in this program, it is estimated that FDA’s actions are allowing PEPFAR to spend $150 million more each year on patient access to care,” FDA commissioner Margaret Hamburg said at a recent event marking the approval. “I look forward to developing and expanding FDA’s international collaborations.”

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