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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  peptide fraction derived from porcine brain protein
Trade Name:  Cerebrolysin
Date Designated:  04/05/2016
Orphan Designation:  Treatment of frontotemporal dementia, including all subvariants
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
EVER Neuro Pharma GmbH
3 Oberburgau
4866 Unterach

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