The PEPFAR database includes all ARV drugs tentatively approved and approved that are reviewed by FDA in association with PEPFAR. The database also includes ARV drugs not reviewed in association with PEPFAR but eligible for listing in the database after meeting certain stability conditions; these products are noted with a * in the FDA Original Action Sequence for PEPFAR number field.

FDA ARV drugs NOT reviewed in association with PEPFAR and NOT eligible for listing are not included in the PEPFAR database. Limited information about all FDA-approved ARV drugs may be found in Drugs@FDA.

Prior to January 29 , 2020, a static table of Tentatively Approved and Approved Antiretrovirals Eligible for Procurement Under the President's Emergency Plan for AIDS Relief was available with the authorization of each company that sponsored the application. All information from the former web table is included in the PEPFAR database.

FDA plays an integral role in PEPFAR by ensuring safe and effective ARV drugs are available for procurement through PEPFAR so these drugs can get to countries with high rates of HIV infection in a timely manner. Since 2004, FDA has encouraged sponsors worldwide to submit U.S. marketing applications for single entity, fixed-combination, and co-packaged versions of previously approved ARV drugs. To speed up approval, FDA uses its existing processes including expedited review for PEPFAR ARV drugs, while ensuring that these products meet the same standards as similar products for the U.S. market and our own citizens.

FDA's specific activities in support of PEPFAR are as follows:

• FDA reviews original marketing applications using its normal standards for approval. Drugs that would otherwise receive “final” approval, but because of the existence of a patent and/or exclusivity, receive “tentative” approval. Drugs that are tentatively approved are not eligible for marketing in the U.S. but can be distributed outside the U.S., and money from the PEPFAR program can be used to procure them, usually at a cost savings to the program.
• FDA reviews amendments to tentatively approved and approved applications that allow for manufacturing changes and other modifications that can lead to reduced cost of ARV drugs.
• Very importantly, FDA engages with ARV companies to assist them in the submission of drug applications for ARV drugs and fixed-combinations needed to meet the demands of worldwide treatment of HIV.
• FDA collaborates with global health entities such as the World Health Organization (WHO), which recognizes FDA-approved or tentatively approved ARV drugs on its lists of quality-assured drugs.  

In addition to the tentatively approved and approved ARV drugs that are eligible for procurement under PEPFAR, there is a separate list of ARV drugs and ARV fixed-combinations that are most needed to meet the needs of HIV treatment in the developing world and PEPFAR countries. Companies should refer to this list when considering submission of applications for ARV drugs intended for PEPFAR use.

When an application is withdrawn by the company that sponsored the application, all non-public information authorized for posting by the sponsor is removed. The application number, application type, established name, active ingredient, strength, dosage form, formulation, company, current approval status, application status history, and company contact information remain available. All other information about the application is removed from the PEPFAR database.

The FDA Original Action Sequence for PEPFAR is assigned based on the original action date. Therefore, FDA Sequence number 1 is assigned to the application with the oldest original action. Subsequent actions such as other types of approvals or withdrawal of the application do not change the FDA Sequence number.

Information provided in the field “Currently Manufactured?” is further explained as:

• Yes = Company that sponsored the application is currently manufacturing the finished drug product
• No = Company that sponsored the application is NOT currently manufacturing the finished drug product

Current manufacturing information comes directly from the company that sponsored the application and is updated at least annually. For more up-to-date information on the current manufacturing status of an individual product, please contact the company directly. See Company Contact Information.

Please visit the PEPFAR database Quick Reference Guide.

The PEPFAR database is updated daily.

Most of the information in the PEPFAR database comes from internal systems used by FDA staff to track information about approved and tentatively approved applications except for information provided in the field “Currently Manufactured”. See FAQ #10 for more information.

Sponsors provide authorization to FDA to post certain non-public information on this public website by signing a sponsor authorization form. A letter requesting this authorization was sent from FDA to each company sponsoring an application reviewed under PEPFAR with a current approval status of approved or tentatively approved. Each company appearing in this database with fully populated information fields has provided authorization. The letter was not sent to companies sponsoring only withdrawn applications (see FAQ #7 for more information about withdrawn applications).