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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: spironolactone
Date Designated: 05/22/2014
Orphan Designation: Use in pediatric patients with primary hyperaldosteronism
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CMP Pharma, Inc.
PO Box 147
8026 US Highway 264A
Farmville, North Carolina 27828
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.