Aurobindo Pharma announced that the company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Entecavir tablets, 0.5mg and 1mg.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Baraclude Tablets, 0.5mg and 1mg, of Bristol-Myers Squibb.
According to IMS, Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver. The product has an estimated market size of US $294 million for the twelve months ending June 2015.
Shares of the company gained Rs 20.05, or 2.77%, to trade at Rs 743.05. The total volume of shares traded was 72,523 at the BSE (12.41 p.m., Thursday).