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Treats chronic obstructive pulmonary disease (COPD). Sold as Tudorza Pressair. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Aclidinium Bromide (sold as Tudorza Pressair), first approved Jul 23, 2012, with 1 new use approved and 0 published complete response letters.
First approved: Jul 23, 2012
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $3.9M
First approved in the EU: Jul 20, 2012
First approved in Japan: Mar 26, 2015
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Tudorza Pressair
Part D
$3.9M
-22%
1,359
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
TUDORZA PRESSAIR 400 MCG INHAL: $344.86 per unitBrand · new this year
Approvals in the EU (EMA)
First approved in the EU the same month as the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 32 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Eklira, new ingredientDrugs with a new active ingredient indicated for the relief of symptoms secondary to airway obstructive disorder in chronic obstructive pulmonary disease… · Kyorin Pharmaceutical Co., Ltd. · Mar 26, 2015
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
