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Chronic Obstructive Pulmonary Disease
AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
May 18th, 2008
AstraZeneca (NYSE:AZN) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older. "COPD is a serious, debilitating lung disease affecting 12 million Americans,(1)" said lead investigator Dr. Donald Tashkin of the University of California, Los Angeles (UCLA). "If SYMBICORT receives approval from the FDA to help...
Source: Medical Letter on the CDC & FDA (2008-05-18)
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