The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Tudorza Pressair (aclidinium bromide inhalation powder; AstraZeneca) regarding several labeling changes.
The sNDA proposed changes to the following sections of the prescribing information: Contraindications, Warnings and Precautions, Adverse Reactions, and revisions to the patient information leaflet.
The Contraindications section has been updated to now state severe hypersensitivity to milk proteins and hypersensitivity to aclidinium bromide or any of the excipients. The Warnings and Precautions section has been updated to now include a new “5.5 Immediate Hypersensitivity Reactions” entry. It states that immediate hypersensitivity reactions have occurred after administration of Tudorza Pressair and if such reactions occur, therapy should be discontinued and alternative treatments should be considered. This reaction is also reflected in the Adverse Reactions section.
The patient information leaflet was updated with information on potential additive effects of concomitant anticholinergic therapy. Patients are to inform their doctors if they are taking any anticholinergics (including tiotropium, ipratropium) or atropine.
Tudorza Pressair is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is available as a 400mcg strength as 30- and 60-metered doses.
For more information call (800) 236-9933 or visit Tudorza.com.