Vaccines, Blood & Biologics
-
HepaGam B
Proper Name: Hepatitis B Immune Globulin Intravenous (Human)
Tradename: HepaGam B
Manufacturer: Cangene Corp, License #1201
Indications:
- For the prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Also indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.
- Treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.
-
Supporting Documents
January 15, 2012 Summary Basis For Regulatory Action - HepaGam B (PDF - 112KB)January 13, 2012 Approval Letter - HepaGam B
To include a revision to the package insert to reflect the final clinical study data.April 6, 2007 Approval Letter - HepaGam B FDA Licenses First Biologic Product to Prevent Hepatitis B Reinfection in Liver Transplant Patients
April 6, 2007January 27, 2006 Approval Letter - HepaGam B Summary Basis for Approval - HepaGam B (PDF - 104KB)
January 2006
-
Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
-
-
