RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2020 > 1 > FDA Launches PEPFAR Drug Database

FDA Launches PEPFAR Drug Database

Posted 30 January 2020 | By Michael Mezher 

FDA Launches PEPFAR Drug Database

The US Food and Drug Administration (FDA) on Wednesday unveiled a new database on the various antiretroviral (ARV) HIV drugs available to purchase through the President’s Emergency Plan for AIDS Relief (PEPFAR).
“This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data,” said FDA Commissioner Stephen Hahn.
According to FDA, more than 15 million people around the world have received HIV drugs through PEPFAR since the program’s launch in 2003. The agency has also approved or tentatively approved 222 applications for PEPFAR use, 194 of which are currently available for treatment.
FDA notes that many of the applications are tentatively approved as intellectual property protections prevent their full approval and sale in the US.
While FDA has previously maintained a list of drugs available through PEPFAR, the agency says that the new mobile-friendly database will make it easier to look up information about the drugs, such as their labeling, whether they are suitable for pediatric use, where they are made and storage requirements.
The database also breaks down the numbers of single ingredient, fixed-dose combination and co-packaged products available to purchase through PEPFAR, as well as the approval status for each product.
FDA, Database

Regulatory Focus newsletters

All the biggest regulatory news and happenings.