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FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
Date:2/27/2009

SYMBICORT provides a new, fast-acting(1) combination treatment option for millions of Americans with debilitating lung disease

WILMINGTON, Del., Feb. 27 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.(2) The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month),(2) which found SYMBICORT significantly improved lung function within five minutes of the first dose(1) and sustained that lung function improvement for the duration of the studies.(3) SYMBICORT pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older.(2)

(Photo: http://www.newscom.com/cgi-bin/prnh//PH76700 )

"More than 12 million Americans with COPD struggle each day to live with the debilitating symptoms of COPD,"(4) said Dr. Howard Hutchinson, Chief Medical Officer, AstraZeneca. "With the approval of SYMBICORT in COPD, patients have a new treatment option that can deliver lung function improvement(3) and daily symptom control, together with a rapid onset of action."(5)

COPD is the fourth leading cause of death in the nation.(4) Along with the 12 million Americans who suffer from this disease, some estimate that there are an equal amount of people who have COPD but remain undiagnosed.(4) COPD is a disorder encompassing two serious lung diseases - emphysema and chronic bronchitis(4) -- which res
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