Breckenridge Pharmaceutical Announces Final Approval of its ANDA Entecavir tablets (Baraclude)

Breckenridge Pharmaceutical announced that the U.S. Food and Drug Administration has granted final approval for its 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.