Search Orphan Drug Designations and Approvals

Marketing approved:
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
Sponsor:	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.

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 Jan. 1, 2013, to the present.