Drug firm Cipla today said it has received final approval from the American health regulator to market Entecavir tablets used for 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 United States Food and Drug Administration (USFDA)".
The tablets are generic versions of Bristol-Myers Suibb'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 US sales of approximately USD 206 million for the 12-month period ending October 2016, according to IMS Health, Cipla said.
The company added that the product will be commercially available in the coming weeks.
Shares of Cipla were trading at Rs 577.50 per scrip in morning trade on BSE, up 1.24 per cent from its previous close.
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