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Gocovri FDA Approval History

FDA Approved: Yes (First approved August 24, 2017)
Brand name: Gocovri
Generic name: amantadine hydrochloride
Dosage form: Extended-Release Capsules
Previous Name: ADS-5102
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Levodopa-Induced Dyskinesia

Gocovri (amantadine hydrochloride) is a chrono-synchronous amantadine therapy for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Development Timeline for Gocovri

DateArticle
Aug 24, 2017Approval FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
Jan  6, 2017Adamas Announces U.S. FDA Acceptance of ADS-5102 New Drug Application for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease
Oct 27, 2016Adamas Submits New Drug Application to U.S. FDA for ADS-5102 for the Treatment of Levodopa-induced Dyskinesia in Patients with Parkinson's Disease

Further information

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