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# FDA Approves AstraZeneca NDA for COPD
- URL: https://www.fdaweb.com/fda-approves-astrazeneca-nda-for-copd/
- Published: 2016-04-26T12:00:00.000Z
- Updated: 2026-09-14T20:57:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135501

> FDA has approved an AstraZeneca NDA for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol, indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The product is not indicated for treating asthma or for relieving acute bronchospasm.  
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> The twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta-2 agonist, was approved based on data from the PINNACLE trial program. Data demonstrated that the drug product “achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p < 0.001) versus its mono-components and placebo,” according to the company.  
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> It says Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology, which enables consistent delivery of one or more different medicines from a single metered-dose inhaler.