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Ongentys FDA Approval History

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

Further information

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