Cipla gets US FDA approval for generic Baraclude tablets

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.

Don't be shellfish...Share on Facebook0Share on Google+0Share on LinkedIn0Share on StumbleUpon0Pin on Pinterest0Tweet about this on Twitter0
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Most Popular

To Top