The agency cleared the Breo Ellipta inhaler for long-term use and to control flare-ups in patients with chronic obstructive pulmonary disorder, often called smoker's cough. The lung ailment can cause a number of breathing problems, including chronic bronchitis and emphysema.
Breo Ellipta delivers a combination of two drugs that reduce inflammation in the lungs and relax airways to ease breathing. The drug carries a warning that it is not approved for asthma.
Glaxo, a leader in respiratory medicine, already sells the asthma treatment Advair, its best-selling product with more than $4 billion in sales per year. The British drugmaker collaborated on the inhaler with South San Francisco-based Theravance.