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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  iclaprim
Trade Name:  N/A
Date Designated:  09/14/2017
Orphan Designation:  Treatment of Staphylococus aureus lung infections in patients with cystic fibrosis
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Motif Bio PLC
330 Madison Avenue
6th Floor
New York, New York 10017

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