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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pulmonary surfactant replacement, porcine
Trade Name: Curosurf
Date Designated: 08/02/1993
Orphan Designation: For the treatment and prevention of respiratory distress syndrome in premature infants.
Orphan Designation Status: Designated/Approved
Chiesi USA, Inc.
175 Regency Woods Place
Suite 600
Cary, North Carolina 27518
United States

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

Marketing approved:

1 Generic Name: Pulmonary surfactant replacement, porcine
Trade Name: Curosurf
Marketing Approval Date: 11/18/1999
Approved Labeled Indication: Treatment (rescue) of respiratory distress syndrome in premature 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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