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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
Marketing Approval Date:  11/18/1999 
Approved Labeled Indication:  Treatment (rescue) of respiratory distress syndrome in premature infants.
Exclusivity End Date:     
Exclusivity Protected Indication* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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