Regulatory

US FDA clears Cangene's anti-hepatitis B product

Last Updated: 2007-04-06 14:00:11 -0400 (Reuters Health)

WASHINGTON (Reuters) - Cangene Corp. won U.S. approval to promote its injectable HepaGam B product to prevent reinfection with the hepatitis B virus in certain liver transplant patients, health officials said on Friday.

HepaGam B is an immune globulin product derived from human plasma that can provide immunity against the hepatitis B virus, the Food and Drug Administration said.

Patients must receive injections at the time of liver transplant and throughout their lives, the FDA said. Liver transplant patients already exposed to the virus face a higher risk of reinfection because they have weakened immune systems, the FDA said.

HepaGam B was FDA-approved in January 2006 for preventing hepatitis B infection after various types of exposure.