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List of Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan

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English: Web Page


This is a list of approved antiretrovirals for PEPFAR. This initiative included an expedited review process for some drug formulations. FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - even if there was still patent or exclusivity market protection for the product in the U.S.

Publisher: U.S. Food and Drug Administration
Language: English
Format: Web Page
Region: Global
Audiences: Doctors/Physicians, Nurses, Physician's Assistants/Nurse Practitioners
Topic Area: Antiretroviral Treatment & Complications
Resource Type: Clinical Tools