Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats relapsing forms of multiple sclerosis (MS). Sold as Gilenya. Every FDA application for this active ingredient: 1 branded and 19 generic.
As of Nov 15, 2026, FDA lists 20 applications for Fingolimod Hydrochloride (sold as Gilenya), first approved Sep 21, 2010, with 2 new uses approved and 0 published complete response letters.
First approved: Sep 21, 2010
Applications: 20
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $93.0M
First approved in the EU: Mar 17, 2011
First approved in Japan: Sep 26, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 12 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Imusera, new ingredientDrugs with a new active ingredient indicated for the prevention of relapse and for delaying the accumulation of physical disability in multiple sclerosis. · Novartis Pharma K.K. · Sep 26, 2011
Clinical Trials
16 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Novartis
Zydus Pharms
Accord Hlthcare
Apotex
Mylan
Alembic