Posted by Michael Wonder on 09 Dec 2016
Cipla receives final FDA approval for generic Baraclude tablets
8 December 2016 - Cipla has received final approval for its abbreviated new drug application for entecavir 0.5 mg and 1 mg tablets from the 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 U.S. 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.
