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US FDA grants pediatric exclusivity to AstraZeneca's asthma inhaler

The U.S. FDA granted AstraZeneca PLC's Symbicort inhalation aerosol six months of pediatric exclusivity.

The decision was based on the evaluation of trials in children aged 6 to 12 years with asthma, in response to a written request by the company.

Symbicort is approved in the U.S. to treat asthma in patients 12 years and older. The inhaler is also approved for the maintenance treatment of chronic obstructive pulmonary disease in adults.