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US FDA Approved and Tentatively Approved ARVs

This President's Emergency Plan for AIDS Relief (PEPFAR) Database, hosted on the US Food and Drug Administration (US FDA) website, indicates all approved and tentatively approved ARVs eligible for procurement under the PEPFAR Program. Providers, patients, and procurers can easily access FDA-reviewed product labeling and package labels for each drug product as well as updates on manufacturing sites, shelf-life, and other information. The product labeling includes information about dosage and administration, warnings and precautions, contraindications, adverse events, pediatric use, and more. The additional information is provided with authorization from each company that sponsored the application.



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The goal of the HIV New Product Introduction Toolkit is to stimulate conversations between government, partners, and communities on new product introduction. Please feel free to share any thoughts, questions, or additional resources for consideration by contacting us via email at HIVToolkit@clintonhealthaccess.org.

 

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