Product Approval Information
Proper Name: Botulism Immune Globulin Intravenous (Human)
Tradename: BabyBIG
Manufacturer: California Department of Health Services, License #1622
Package Insert (PDF - 51 KB) - October, 2003
Date: October 23, 2003
Indication: Treatment of infant botulism caused by type A or type B Clostridium botulinum
October 23, 2003 Approval Letter
Summary Basis of Approval (PDF - 45 KB)
Clinical Review (PDF - 245 KB)