Aurobindo Pharma Limited has received tentative approval to manufacture and market Efavirenz+Lamivudine+Tenofovir Disoproxil Fumarate tablets, 600mg, 300mg, 300mg, from the US Food & Drug Administration (USFDA).
The new drug application (NDA) provides for the treatment of HIV-1 infection in adults and adolescents aged more than 16 years of age and weighing at least 40 kg, the company stated in a press release on Friday.
This new drug application was reviewed under the President's Emergency Plan for AIDS Relief (PEPFAR). The estimated ARV (anti-retroviral) access market (emerging markets) for the product was $120 million last year and is expected to record strong growth in the coming year.
Aurobindo now has a total of 191 abbreviated NDA approvals (163 final approvals, including 4 from Aurolife Pharma LLC, and 28 tentative approvals) from the USFDA.