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Fingolimod hcl

FDA Drug Profile — Gilenya, fingolimod

Drug Details

Generic Name
Fingolimod hcl
Brand Names
Gilenya, fingolimod
Application Number
NDA022527
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
4
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
FINGOLIMOD HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE GILENYA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )