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ozanimod hydrochloride

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

Drug Details

Generic Name
ozanimod hydrochloride
Brand Names
ZEPOSIA, ZEPOSIA 7-Day Starter Pack, ZEPOSIA Starter Kit
Application Number
NDA209899
Sponsor
Celgene International Sarl
NDC Codes
6
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 )