Aurobindo Pharma has received the tentative approval to manufacture and market Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets, 600mg/300mg/300mg from the US Food & Drug Administration (US FDA).
The New Drug Application (NDA) 22-343 provides for the use of Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate Tablets, 600mg/300mg/300mg alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents aged more than 16 years of age and weighing at least 40 kg.
This NDA was reviewed under the President’s Emergency Plan for AIDS Relief (PEPFAR). The estimated ARV Access Market (Emerging Markets) for the product is $120 million last year and expected to record strong growth in the coming year.
Aurobindo now has a total of 191 ANDA approvals (163 final approvals including four from Aurolife Pharma and 28 tentative approvals) from US FDA.
EP News Bureau – Mumbai