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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Fluoxetine
Date Designated: 04/30/1999
Orphan Designation: Treatment of autism.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neuropharm, Ltd.
Felcham Park House
Surrey
United Kingdom

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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