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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: Pentam 300
Date Designated: 02/28/1984
Orphan Designation: Treatment of Pneumocystis carinii pneumonia.
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: Pentam 300
Marketing Approval Date: 10/16/1984
Approved Labeled Indication:
Exclusivity End Date: 10/16/1991 
Exclusivity Protected Indication* :  

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