Cipla receives final approval from USFDA for generic Baraclude tablets

08 Dec 2016 Evaluate

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 (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 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.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries.


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