FDA Says AstraZeneca Lacks Data to Establish Approriateness of SYMBICORT in Children

The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to AstraZeneca for SYMBICORT pressurized metered dose inhaler for the long-term maintenance treatment of asthma in pediatric patients ages 6-11 years. The FDA stated that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the individual components of SYMBICORT—budesonide and formoterol. The FDA also indicated that AstraZeneca needed to establish how the individual components contribute to the combination product, in pediatric patients ages 6 to 11 years.  AstraZeneca is evaluating the CRL and expected to provide a response to the FDA.
 
SYMBICORT was approved in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older in July 2006 and in February 2009 for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. The CRL does not impact the current prescribing information for the treatment of patients taking SYMBICORT for approved indications in asthma and COPD.