FDA OKs Nexium DR in 12-17yr-olds

7 May 2006

Anglo-Swedish drug major AstraZeneca says that the US Food and Drug Administration has approved the use of Nexium (esomeprazole magnesium), its delayed-release capsules, in children aged 12 to 17 for the short-term treatment of gastroesophageal reflux disease.

The safety of the proton pump inhibitor in these adolescents was evaluated in a multicenter, randomized, double-blind parallel-group study in which a total of 149 patients, ages 12 to 17, with clinically-diagnosed GERD were treated with either 20mg or 40mg once a day for up to eight weeks.

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