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AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
Date:5/30/2008

soon as the patient is able to resume treatment with NEXIUM Delayed-Release Capsules. Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with a history of erosive esophagitis for more than 10 days have not been demonstrated.

For more information visit http://www.NEXIUM-US.com.

About NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules

In adults, NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

NEXIUM received approval in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients ages 12 to 17 years old. NEXIUM is now approved for the short-term treatment (up to 8 weeks) of GERD in children ages 1 to 11 years old. The approvals are supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies. The safety and effectiveness of NEXIUM for the treatment of GERD in patients less than 1 year of age have not been established. The safety and effectiveness of NEXIUM for other pediatric uses have not been established.

In adults, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. In patients 1 to 17 years of age, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. <
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SOURCE AstraZeneca
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