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Cipla Receives USFDA Final Approval For Generic Baraclude Tablets

  • Post By: YYogesh Joshi
  • 08 Dec 2016
Cipla Receives USFDA

Cipla Ltd, a global pharmaceutical company 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).

Product will cater to the US market
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.

Cipla portfolio includes over 1000 products
Cipla pharmaceutical company portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally.