Cipla receives final approval for generic Entecavir tablets

Cipla has in its BSE announcement declared that it has received final approval for its Abbreviated New Drug Application (ANDA) for Entecavir tablets USP 0.5 mg and 1 mg, from the United States Food and Drug Administration (USFDA).

Entecavir tablets, USP 0.5 mg and 1 mg, are AB-rated generic equivalents of Bristol-Myers Squibb’s Baraclude tablets 0.5 mg and 1 mg and are indicated for the treatment of chronic Hepatitis B virus infection. Baraclude tablets and generic equivalents had U.S. sales of approximately $206 mn for the 12-month period ending October 2016, according to IMS Health. The product will cater to the US market and will be commercially available in the coming weeks.

Cipla is a global pharmaceutical company having a portfolio that includes over 1000 products across wide range of therapeutic categories with one quality standard globally.

The stock has delivered negative 10 per cent return over the past one year. However, over the last six-month period, the stock has delivered 23 per cent return.