Generics
Breckenridge Pharmaceutical wins final US FDA approval for Entecavir tablets (Baraclude) ANDA for hepatitis B infection
28 March 2018 -

Pharmaceutical company Breckenridge Pharmaceutical Inc reported on Tuesday the receipt of final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Entecavir tablets USP in 0.5mg and 1mg for the treatment of chronic hepatitis B virus infection.

The company said Entecavir tablets USP in 0.5mg and 1mg are a generic version of Baraclude Tablets by Bristol-Myers Squibb Company.

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 two year of age. Baraclude generated combined annual sales of USD95.9m, according to MAT January 2018 IQVIA sales data.

Breckenridge Pharmaceutical added that Entecavir tablets USP, developed in collaboration with Welding GMBH & Co, are manufactured by RA Chem Pharma Limited and supplied to Breckenridge for exclusive distribution in the US.

Following the US FDA approval, Breckenridge will launch Entecavir tablets in the US market with immediate effect.

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