The Food and Drug Administration has approved a new pediatric formulation of AstraZeneca's asthma medication, Accolate (zafirlukast), for use in patients 7 years of age and older. The product will be available in a 10 mg, non-flavored mini tablet specifically designed for children. Recommended dosing is one 10 mg mini tablet twice daily, even during symptom-free periods.
Safety data from the Accolate pediatric clinical trials, involving nearly 800 pediatric subjects, found Accolate to be well-tolerated; long-term safety of Accolate in pediatric patients was further confirmed in a 52-week, open label extension trial. The adverse event profile for subjects who were treated with Accolate was similar to the profile for subjects treated with placebo.
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