AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application
AstraZeneca has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the new drug application for AXANUM (aspirin/esomeprazole magnesium) tablets. The company also received a CRL for the supplemental new drug application (sNDA) for NEXIUM (esomeprazole magnesium).
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.
AstraZeneca 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.
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NOTES TO EDITORS:
Axanum is a fixed-dose combination containing low-dose ASA (acetylsalicylic acid) and the active ingredient of the PPI Nexium® (esomeprazole, formulated as enteric coated pellets) 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 a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com