selegiline

FDA Drug Profile — EMSAM

Drug Details

Generic Name
selegiline
Brand Names
EMSAM
Application Number
NDA021336
Sponsor
Viatris Specialty LLC
NDC Codes
3
Dosage Forms
PATCH
Routes
TRANSDERMAL
Active Ingredients
SELEGILINE

Indications and Usage

1 INDICATIONS AND USAGE ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy [see Clinical Studies (14 ) ]. ZELAPAR, a monoamine oxidase type B (MAO-B) inhibitor, is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy ( 1 )