The FDA has approved the Symbicort budesonide/formoterol fumarate 80/4.5 μg MDI for the treatment of asthma in patients aged 6-12, AstraZeneca has announced. The company previously announced that it had received pediatric exclusivity for the product.
Symbicort inhalation aerosol has been approved in the US for the treatment of asthma in patients 12 and up since 2006 and for the treatment of COPD in adults since 2009.
AstraZeneca VP, Medical Affairs, and US Head Medical Officer Gregory Keenan commented, “Symbicort is a cornerstone product in our growing respiratory franchise and we are pleased to now be able to offer this medicine to younger patients, helping to control and prevent asthma symptoms.”
