The FDA has stated that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the individual components of Symbicort – budesonide and formoterol – and to establish how the individual components contribute to the combination product, in pediatric patients ages six to 11 years. AstraZeneca is evaluating the complete response letter and will provide a response to the agency in due course.
Symbicort was approved in the US in July 2006 for the long-term maintenance treatment of asthma in patients 12 years of age and older and in February 2009 for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.