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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Pentamidine isethionate
Trade Name: Nebupent
Date Designated: 01/12/1988
Orphan Designation: Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease.
Orphan Designation Status: Designated/Approved
Fujisawa USA, Inc.
3 Parkway North Center
Deerfield, Illinois 60015
United States

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

Marketing approved:

1 Generic Name: Pentamidine isethionate
Trade Name: Nebupent
Marketing Approval Date: 06/15/1989
Approved Labeled Indication:
Exclusivity End Date: 06/15/1996 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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