FDA OKs Baraclude generic from Aurobindo

Dayton, N.J. — Aurobindo Pharma Limited announced Thursday that it had received approval from the Food and Drug Administration for its entecavir tablets in 0.5- and 1-mg dosage strengths.

 

The drug is a generic of Bristol-Myers Squibb’s Baraclude. Entecavir tablets are meant to treat chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.        

 

Entecavir has an estimated market size of $310.3M for the twelve months ending April 2015, according to IMS Health.