FDA Approves Use of NEXIUM(R) in Children With GERD
Monday May 1, 2006
AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved the use of NEXIUM® (esomeprazole magnesium) delayed release capsules, in children ages 12 to 17 for the short-term treatment of gastroesophageal reflux disease (GERD).
The safety of NEXIUM in adolescents ages 12 to 17 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 NEXIUM 20 mg or NEXIUM 40 mg once daily for up to eight weeks. The use of NEXIUM in children ages 12 to 17 years is supported by extrapolation of results from adequate and well-controlled studies in adults and additional safety and pharmacokinetics studies in adolescents' ages 12 to 17.
The most frequently reported treatment related adverse events were headache, abdominal pain, diarrhea and nausea. No safety concerns were identified.
Additional Resources:
The safety of NEXIUM in adolescents ages 12 to 17 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 NEXIUM 20 mg or NEXIUM 40 mg once daily for up to eight weeks. The use of NEXIUM in children ages 12 to 17 years is supported by extrapolation of results from adequate and well-controlled studies in adults and additional safety and pharmacokinetics studies in adolescents' ages 12 to 17.
The most frequently reported treatment related adverse events were headache, abdominal pain, diarrhea and nausea. No safety concerns were identified.
Additional Resources:
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