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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: calfactant
Trade Name: Infasurf
Date Designated: 06/07/1985
Orphan Designation: Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.
Orphan Designation Status: Designated/Approved
ONY Biotech Inc.
1576 Sweet Home Road
Amherst, New York 14228
United States

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

Marketing approved:

1 Generic Name: calfactant
Trade Name: Infasurf
Marketing Approval Date: 07/01/1998
Approved Labeled Indication: Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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