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Ongentys FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved April 24, 2020)
Brand name: Ongentys
Generic name: opicapone
Dosage form: Capsules
Company: Neurocrine Biosciences, Inc.
Treatment for: Parkinson's Disease

Ongentys (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Development timeline for Ongentys

Apr 27, 2020Approval FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes
Jul 10, 2019Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease
Feb 14, 2018Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson's Disease Based on Existing Pivotal Clinical Trial Data

Further information

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