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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Amantadine hydrochloride
Trade Name:  Gocovri
Date Designated:  04/09/2015
Orphan Designation:  Treatment of levodopa-induced dyskinesia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/24/2017 
Approved Labeled Indication:  treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy with or without concomitant dopminergic medications
Exclusivity End Date:    08/24/2024 
Exclusivity Protected Indication* :  treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy with or without concomitant dopminergic medications
Adamas Pharmaceuticals, Inc.
1900 Powell Street
Suite 750
Emeryville, California 94608
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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