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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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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 Public Health
850 Marina Bay Parkway, E-361
Richmond, California 94804
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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