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For Parkinson’s disease (PD) experiencing “off” episodes. NDA 212489, held by Amneal. Opicapone.
As of Nov 13, 2026, NDA 212489 (Ongentys), held by Amneal, was first approved by FDA on Apr 24, 2020, with 2 approved supplements and 0 published complete response letters.
First approved: Apr 24, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
