Express Pharma

Cipla receives final approval for generic Baraclude tablets

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Entecavir tablets are indicated for the treatment of chronic Hepatitis B virus infection

Cipla 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 (US FDA).

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 $206M 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.

EP News Bureau

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