FDA approves Breckenridge’s generic Baraclude
Breckenridge Pharmaceutical has received Food and Drug Administration approval for its generic Baraclude (entecavir). The drug is indicated as a treatment for chronic hepatitis B.
Breckenridge’s generic Baraclude will be available in 0.5- and 1-mg dosage strengths. The drug will be manufactured by RA Chem Pharma, with Breckenridge as the exclusive U.S. distributor.
The generic and branded versions of Baraclude had combined U.S. sales of roughly $95.9 million for 12 months ended January 2018, according to IQVIA data.
Breckenridge’s generic Baraclude will be available in 0.5- and 1-mg dosage strengths. The drug will be manufactured by RA Chem Pharma, with Breckenridge as the exclusive U.S. distributor.
The generic and branded versions of Baraclude had combined U.S. sales of roughly $95.9 million for 12 months ended January 2018, according to IQVIA data.