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news.AstraZeneca has obtained a complete response letter (CRL) from FDA for its new drug application for Axanum (aspirin/esomeprazole magnesium) tablets. Additionally it has also received a CRL for the supplemental new drug application (sNDA) for Nexium (esomeprazole magnesium).
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Axanum is a fixed-dose combination containing low-dose ASA (acetylsalicylic acid) and the active ingredient of the PPI Nexium developed by AstraZeneca for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment, and at risk for developing ASA associated gastric and/or duodenal ulcers.
AstraZeneca is currently evaluating the CRLs, and will continue discussions with the FDA to determine next steps with respect to both the Axanum NDA as well as the Nexium sNDA and will respond to the agency’s request for additional information.
Earlier, AstraZeneca had submitted both applications to the FDA on April 30, 2009, seeking approval for Axanum, for the risk reduction of low dose ASA-associated gastric and/or duodenal ulcers in patients at risk. The Nexium sNDA was submitted for the risk reduction of low-dose aspirin-associated peptic ulcers.