> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Circassia Pharma OK’s sNDA for Tudorza Pressair
- URL: https://www.fdaweb.com/circassia-pharma-oks-snda-for-tudorza-pressair/
- Published: 2019-04-01T12:00:00.000Z
- Updated: 2026-09-15T01:17:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143752

FDA has approved a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressair’s (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that the therapy reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.  
  
In the study, adverse reactions occurring at a rate greater than 2% over the placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease. Tudorza Pressair is indicated for the maintenance treatment of patients with COPD.