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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 (inhalation)
Date Designated: 10/05/1987
Orphan Designation: Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Fisons Corporation
755 Jefferson Rd., P.O. Box 1710
Rochester, New York 14603
United States

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

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