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AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

Mon, 05/04/2009 - 4:40am
AstraZeneca has announced the submission of a new drug application (NDA) to the U.S.Food and Drug Administration (FDA) seeking approval for a product combininglow dose aspirin with esomeprazole magnesium for the risk reduction of lowdose aspirin-associated gastric and/or duodenal ulcers in patients at risk.AstraZeneca also submitted a supplemental new drug application (sNDA) forNEXIUM(R) (esomeprazole magnesium) for the risk reduction of low doseaspirin-associated gastric and/or duodenal ulcers. NEXIUM already is approvedfor the risk reduction in the occurrence of gastric ulcers associated withcontinuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients atrisk for developing gastric ulcers.

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