Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: synthetic surfactant comprised of DPPC, POPG Na, synthetic SP-C analogue and synthetic SP-B analogue
Date Designated: 03/16/2012
Orphan Designation: Treatment of preterm neonatal respiratory distress syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan 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 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-