opicapone

FDA Drug Profile — ONGENTYS

Drug Details

Generic Name
opicapone
Brand Names
ONGENTYS
Application Number
NDA212489
Sponsor
Amneal Pharmaceuticals LLC
NDC Codes
3
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
OPICAPONE

Indications and Usage

1 INDICATIONS AND USAGE ONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ( 1 )