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Axanum receives complete response

June 2, 2010 1:11 AM UTC

FDA issued a complete response letter for an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Axanum aspirin/esomeprazole to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers. The agency also issued a complete response letter for an sNDA for Nexium esomeprazole to reduce the risk of low-dose aspirin-associated peptic ulcers. AstraZeneca did not disclose details of the letters but said it is discussing next steps with FDA. ...