Aurobindo gets US FDA approval for generic of Baraclude

Indian drugmaker Aurobindo Pharma (BSE: 524804) has received the final approval from the US Food and Drug Administration to manufacture and market entecavir tablets, 0.5mg and 1mg.

The company says the approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Baraclude from US pharma major Bristol-Myers Squibb (NYSE: BMY).

Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver. The product has an estimated market size of $294 Million for the 12 months ending June 2015 according to IMS data quoted by Aurobindo.

This is the 44th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India, for manufacturing oral non-antibiotic products. Aurobindo now has a total of 209 ANDA approvals (181 Final approvals including nine from Aurolife Pharma and 28 Tentative approvals) from US FDA.