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Zeposia FDA Approval History

Last updated by Judith Stewart, BPharm on June 1, 2021.

FDA Approved: Yes (First approved March 25, 2020)
Brand name: Zeposia
Generic name: ozanimod
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Zeposia (ozanimod) 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; and moderately to severely active ulcerative colitis (UC) in adults.

Development Timeline for Zeposia

DateArticle
May 27, 2021Approval  FDA Approves Bristol Myers Squibb’s Zeposia (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
Mar 26, 2020Approval  FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis
Jun  6, 2019US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
Mar 25, 2019Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
Feb 27, 2018Celgene Provides Regulatory Update on Ozanimod for the Treatment of Relapsing Multiple Sclerosis

Further information

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