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FDA Approves NEXIUM(R) for the Treatment of Short-Term GERD in Children 1 to 11 Years Old
Date:2/28/2008

--New 10 mg Dose Formulation for Oral Suspension Also Approved--

WILMINGTON, Del., Feb. 28 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) announced today 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 untreated, can lead to potentially serious complications such as erosive esophagitis," said Mark A. Gilger, MD, Chief of Service, Gastroenterology, Hepatology and Nutrition, Texas Children's Hospital. "GERD isn't just a condition that affects adults. Researchers estimate children ages 3 to 17 years old report GERD symptoms roughly 2% to 8% of the time."(2) The availability of a proven, effective treatment like NEXIUM with an established safety profile is an important step in the treatment of this chronic condition."

The FDA has also approved a new 10 mg dose formulation of NEXIUM for Delayed-Release Oral Suspension for use in children 1 to 11 years old. This 10 mg dose formulation is in addition to the 20 and 40 mg NEXIUM for Delayed- Release Oral Suspension, which were approved in October 2006 for use in adolescent patients 12 to 17 years old, as well as adults. The new 10 mg dose formulation contains esomeprazole magnesium, the same active ingredient used in NEXIUM Delayed-Release Capsules. The 10 mg dose is a granular formulation that is mixed with water to form a suspension that is administered orally or via enteral (feeding) tubes. The 10 mg dose of NEXIUM(R) (eso
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SOURCE AstraZeneca
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