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Cipla gets US FDA approval for generic Baraclude tablets

cipla-us-fda-approval

Cipla Ltd has received final approval for its ANDA for entecavir tablets USP 0.5 mg and 1 mg, from the US FDA.cipla-us-fda-approval

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 a hepatitis B virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection.

Baraclude tablets and generic equivalents had US sales of approximately $206 million 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.

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