17 April 2019 - Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information.
Circassia Pharmaceuticals today announced that the US Food and Drug Administration has approved Duaklir Pressair (aclidinium bromide and formoterol fumarate) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
The FDA approval of DUAKLIR PRESSAIR is based on data from several studies including ACLIFORM, AUGMENT, and the recently-published AMPLIFY clinical trial.