FDA denies extended use of AstraZeneca's Symbicort for children

NEW YORK The Food and Drug Administration has rejected an application from AstraZeneca seeking approval for the use of an inhaler to treat asthma in children ages 6 to 11.

The Anglo-Swedish drug maker said the FDA gave it a complete response letter, stating the company did not provide adequate data to establish the appropriate dosage of the individual components of Symbicort (budesonide and formoterol) and to establish how the individual components contribute to the combination product in children.

The company said it is evaluating the letter and will respond to the FDA in due course.