Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Botulism immune globulin
Trade Name: BabyBIG
Date Designated: 01/31/1989
Orphan Designation: Treatment of infant botulism.
Orphan Designation Status: Designated/Approved
California Department of Health Services
2151 Berkeley Way
Berkeley, California 94704
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Botulism immune globulin
Trade Name: BabyBIG
Marketing Approval Date: 10/23/2003
Approved Labeled Indication: Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.
Exclusivity End Date: 10/23/2010 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-