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AZ's Symbicort suffers setback

AstraZeneca has been denied approval by the FDA for the use of its asthma drug Symbicort in children aged 6-11 years old

AstraZeneca has been denied approval by the US Food and Drug Administration (FDA) for the use of its asthma drug Symbicort in children aged 6-11 years old.

The company received a Complete Response Letter (CRL) from the FDA that said the company had failed to provide adequate data to establish the appropriate doses of the individual components of Symbicort, budesonide and formoterol, and to establish how the components contribute to the complete product when used in children aged 6-11 years old. AstraZeneca will send the FDA a response to the CRL in due course.

Symbicort was approved in the US for use in children over 12 years old for long-term maintenance of asthma in July 2009. In February 2009, Symbicort was approved in the US for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), such as chronic bronchitis and emphysema.

Current treatment with Symbicort is not affected by the CRL.

7th April 2009

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