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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Pramiracetam Sulfate
Date Designated: 11/04/1991
Orphan Designation: For the management of cognitive dysfunction and enhancement of antidepressant activity associated with electroconvulsive therapy.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cambridge Neuroscience, Inc.
1 Kendall Square, Bldg. 700
Cambridge, Massachusetts 02139
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.
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