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GOCOVRI for Dyskinesia Gets Orphan Drug Designation


(October 26, 2017) - The US Food and Drug Administration (FDA) Office of Orphan Drug Products has designated a 7-year orphan drug exclusivity for amantadine (GOCOVRI) extended-release capsules. GOCOVRI, the only FDA-approved therapy for dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy — with or without concomitant dopaminergic medications — was originally approved on August 24. Its exclusive orphan drug status will run through August 24, 2024. Read more