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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Ibuprofen lysine
Trade Name: NeoProfen
Date Designated: 10/29/1996
Orphan Designation: Treatment of patent ductus arteriosus
Orphan Designation Status: Designated/Approved
Lundbeck, Inc.
Four Parkway North
Deerfield, Illinois 60015
United States

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

Marketing approved:

1 Generic Name: Ibuprofen lysine
Trade Name: NeoProfen
Marketing Approval Date: 04/13/2006
Approved Labeled Indication: For closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective
Exclusivity End Date: 04/13/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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