AstraZeneca

FDA Approves NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old

Published in FDA Law Weekly, March 13th, 2008

AstraZeneca (NYSE:AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the use of NEXIUM(R) (esomeprazole magnesium) in children ages 1 to 11 years old for the short-term treatment of gastroesophageal reflux disease (GERD) for up to 8 weeks,(1) helping to address an important unmet need for pediatric patients.

NEXIUM received approval in April 2006 for adolescents 12 to 17 years old for the treatment of GERD, a condition in which the contents of the stomach back up into the esophagus. Symptoms of GERD often include heartburn, regurgitation and upset stomach.

"GERD has become increasingly common in children, and, if left...

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Source: FDA Law Weekly (2008-03-13)

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