Cipla gets final USFDA nod for Baraclude tablets

Mumbai: Cipla Ltd, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, 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 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.