ozanimod hydrochloride

FDA Drug Profile — ZEPOSIA 7-Day Starter Pack, ZEPOSIA Starter Kit, ZEPOSIA

Drug Details

Generic Name
ozanimod hydrochloride
Brand Names
ZEPOSIA 7-Day Starter Pack, ZEPOSIA Starter Kit, ZEPOSIA
Application Number
NDA209899
Sponsor
Celgene International Sarl
NDC Codes
9
Dosage Forms
CAPSULE, KIT
Routes
ORAL
Active Ingredients
OZANIMOD HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE ZEPOSIA 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 adults. moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA 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 adults. ( 1 ) Moderately to severely active ulcerative colitis (UC) in adults. ( 1 )