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FDA Approves Bevespi Aerosphere for Patients with COPD

AstraZeneca news release; 2016 Apr 25

The FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol for patients with chronic obstructive pulmonary disease (COPD).

Indication: Bevespi Aerosphere is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD, including bronchitis and/or emphysema. It is not indicated to treat asthma or for the relief of acute bronchospasm.

Dosage and administration: For oral inhalation only. Maintenance treatment of COPD is 2 inhalations twice daily.

Adverse reactions: The most common adverse reactions (incidence ≥2% and more common than with placebo) include urinary tract infection and cough.

Citation: BEVESPI AEROSPHERE™ approved by the US FDA for patients with COPD. [news release]. Wilmington, DE: AstraZeneca; April 25, 2016: http://www.astrazeneca-us.com/media/press-releases/Article/20160425-bevespi-aerosphere-approved-by-the-us-fda-for-patients. Accessed May 9, 2016.