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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Colfosceril palmitate, cetyl alcohol, tyloxapol
Trade Name: Exosurf Neonatal for Intratracheal Suspension
Date Designated: 10/20/1989
Orphan Designation: 1. Prevention of hyaline membrane disease, also known as respiratory distress syndrome, in infants born at 32 weeks gestation or less 2. prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: Colfosceril palmitate, cetyl alcohol, tyloxapol
Trade Name: Exosurf Neonatal for Intratracheal Suspension
Marketing Approval Date: 08/02/1990
Approved Labeled Indication: Prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32 weeks gestation or less and in the treatment of established HMO at all gestational ages
Exclusivity End Date: 08/02/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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