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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Respiratory syncytial virus immune globulin (Human)
Trade Name: Respigam
Date Designated: 09/27/1990
Orphan Designation: Prophylaxis of respiratory syncytial virus lower respiratory tract infections in infants and young children at high risk of RSV disease.
Orphan Designation Status: Designated/Approved
MedImmune & Massachussetts Public Health Biologics Labs.
35 West Watkins Mill Road
Gaithersburg, Maryland 20878
United States

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

Marketing approved:

1 Generic Name: Respiratory syncytial virus immune globulin (Human)
Trade Name: Respigam
Marketing Approval Date: 01/18/1996
Approved Labeled Indication: For the prevention of serious lower respiratory tract infections caused by RSV in children less than 24 months of age with bronchopulmonary dysplasia or a history of prematurity (less than or equal to 35 weeks gestation).
Exclusivity End Date: 01/18/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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