human botulinum neurotoxin a/b immune globulin

FDA Drug Profile — BabyBIG

Drug Details

Generic Name
human botulinum neurotoxin a/b immune globulin
Brand Names
BabyBIG
Application Number
BLA125034
Sponsor
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN

Indications and Usage

1 INDICATIONS AND USAGE BabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age ( 1 ).