FDA Has Approved an Update to The Labeling for Bristol-Myers Squibb's Baraclude

US Food and Drug Administration (FDA) has approved an update to the labeling for Bristol-Myers Squibb's Baraclude to include data on African Americans and liver transplant recipients with chronic hepatitis B infection.

The present labeling update has been granted based on Baraclude study in African-American patients and study in post-liver transplant recipients.

Baraclude, a nucleoside analogue has received approval by the US FDA in March 2005 to treat adult chronic hepatitis B patients with compensated liver disease.

The drug is also used to treat hepatitis B patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Mayo Clinic Hepatology director and liver transplant director Michael Charlton said, "These data included in the BARACLUDE label will help healthcare providers prescribe treatment among chronic hepatitis B patients, including liver transplant recipients."