FDA approves ANDA Entecavir tablets (Baraclude®)

ACG Inspection strengthens fight against falsified medicines
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The U.S. Food and Drug Administration has granted final approval for Breckenridge Pharmaceutical’s Abbreviated New Drug Application for Entecavir tablets USP, 0.5mg and 1mg, a generic version of Baraclude® Tablets by Bristol-Myers Squibb Company.

The product, which was developed in collaboration with Welding GMBH & Co., is manufactured by RA Chem Pharma Limited and supplied to Breckenridge for exclusive distribution in the United States.  Breckenridge will launch the product immediately.

 Entecavir tablets (Baraclude®) are a Hepatitis B virus nucleoside analog reverse transciptase inhibitor for the treatment of chronic hepatitis B virus infection in adults and children at least 2 year of age.  Baraclude® generated combined annual sales of $95.9M, according to MAT January 2018 IQVIA sales data.