FDA Grants Aurobindo Approval for Antiretroviral Therapy
Indian drug manufacturer Aurobindo Pharma has received FDA approval to produce a combination antiretroviral drug, the company announced Thursday, Reuters/NDTVProfit.com reports (Reuters/NDTVProfit.com, 3/16). The approval is for lamivudine 150 mg and zidovudine 300 mg fixed dose tablets packaged with efavirenz 600 mg tablets (Dow Jones, 3/16). Aurobindo Pharma in January was granted tentative approval to produce an oral version of the antiretroviral drug nevirapine for pediatric use under the President's Emergency Plan for AIDS Relief (Kaiser Daily HIV/AIDS Report, 1/5). The Indian drug manufacturer also was granted tentative FDA approval in December 2005 to produce the generic antiretroviral drug stavudine for pediatric use (Kaiser Daily HIV/AIDS Report, 12/22/05).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.