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 moderate to severe plaque psoriasis. Sold as Selarsdi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ustekinumab-Aekn (sold as Selarsdi), first approved Apr 16, 2024, with 0 new uses approved and 1 published complete response letter.
First approved: Apr 16, 2024
Applications: 1
New uses approved: 0
Complete response letters: 1
Medicare spending, 2025: $1.8M
Orphan exclusivity until: Aug 28, 2033
First approved in the EU: Jan 16, 2009
First approved in Japan: Jan 21, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 159 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
1) Stelara1) A drug with a new indication for the remission induction therapy of moderate to severe ulcerative colitis (for use only in patients who have not… · Janssen Pharmaceutical K.K. · Mar 25, 2020
Stelara, new approval(1) A drug with a new route of administration indicated for the induction therapy for moderate to severe active Crohn's disease (for use only in patients… · Janssen Pharmaceutical K.K. · Mar 30, 2017 · Review report
Stelara, new ingredientA drug with a new active ingredient indicated for the treatment of plaque psoriasis and psoriatic arthritis in patients who have not responded sufficiently… · Janssen Pharmaceutical K.K. · Jan 21, 2011 · Review report
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
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
