| | Brand-name FDCs and PEPFAR |
 | | The expedited review shortened the time to weeks, and was designed to encourage companies to invest in the development of fixed dose (creating one pill out of two or three individual drugs), co-packaged (putting two or more pills into single packaging for distribution) antiretroviral drug products. |
 | | Therefore, generic versions of these products couldn't be considered by FDA under their "expedited approval process." All makers of FDCs, right now Gilead and GSK, should promise not to sue generic drug makers in other countries and also release PK, stability and manufacturing data so these companies can reference this for the WHO prequalification process. |
 | | An FDC that combines all needed ARVs into one pill is ultimately preferable; the American FDCs are not stand-alone combinationsthey still requires additional ARV(s) in order to constitute an effective regimen, vs the WHO pre-qualified triple combinations, which are complete treatments. |
| www.aidsinfonyc.org /tag/tx/pepfar.html (597 words) |