DAYTON, N.J. — Aurobindo Pharma Ltd. has gained approval from the Food and Drug Administration for entecavir tablets 0.5 mg and 1 mg, a medication for hepatitis B.
Aurobindo, which announced the product this week, said its entecavir tablets are a generic version of Baraclude tablets (0.5 mg and 1 mg) from Bristol-Myers Squibb.
Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.
The drug had U.S. sales of approximately $310.3 million for the 12 months ended in April 2015, according to IMS Health data reported by Aurobindo.
