[Jun 29, 2006]
FDA on Tuesday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce an oral version of the antiretroviral drug abacavir for pediatric use in children ages three months to 13 years under the President's Emergency Plan for AIDS Relief, Reuters reports (Reuters, 6/27). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under PEPFAR (Kaiser Daily HIV/AIDS Report, 1/5).