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 (USFDA). The New Drug Application (NDA) 22-343 provides for the use of these tablets 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 was $120 million last year and expected to record strong growth in the coming year.
The company now has a total of 191 ANDA approvals (163 Final approvals including 4 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA. Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
