Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Baraclude (entecavir) is 2,993 days for extension of a patent that claims the human drug product. Baraclude is indicated for treating chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. To view this notice, click here.
