Drug firm Cipla Ltd. said it received final approval from the U.S. health regulator to market ‘Entecavir' tablets used for the treatment of Hepatitis B infection.
In a BSE filing, Cipla said, it has received final approval for its abbreviated new drug application (ANDA) for Entecavir tablets USP 0.5 mg and 1 mg from the U.S. Food and Drug Administration.
The tablets are generic versions of Bristol-Myers Squibb's Baraclude tablets of the same strength, Cipla said.
The tablets are indicated for the treatment of chronic Hepatitis B virus infection, it added.
Baraclude tablets and generic equivalents had U.S. sales of approximately $206 million for the 12-month period ending October 2016, according to IMS Health. The company added that the product will be commercially available in the coming weeks.
Shares of Cipla were trading at Rs 578.70 per share as of 1 p.m. on the National Stock Exchange.
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