AstraZeneca Submits sNDA for SYMBICORT® for COPD Treatment

AstraZeneca has announced submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to seek approval of a new indication for SYMBICORT® (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.

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Source: Press release, AstraZeneca, 30.04.2008