Summaries of health policy coverage from major news organizations
Aurobindo Receives Tentative FDA Approval To Produce Oral Version of Generic Antiretroviral Abacavir for PEPFAR
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).
This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.