Regulation

FDA approves TUDORZA PRESSAIR sNDA to include data for reduction of COPD exacerbations and hospitalizations

Circassia Pharmaceuticals announced that the US Food and Drug Administration (FDA) added new data to the TUDORZA PRESSAIR (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.