AstraZeneca has announced that the FDA had granted 6 months of pediatric exclusivity for its Symbicort budesonide/formoterol MDI based on trials in asthmatic children aged 6-12. In August 2016, AstraZeneca announced that its CHASE 3 (ChildHood Asthma Safety and Efficacy) study met its primary endpoint and that it planned to submit the data to the FDA
The Symbicort MDI was approved by the FDA to treat asthma in patients aged 12 and up in July 2006.
Read the AstraZeneca press release.
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