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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 AXANUMTM (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:

About AxanumTM
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.

About AstraZeneca
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

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Karl-Johan Karlsson

Karl-Johan Karlsson

Presskontakt Tf presschef, AstraZeneca AB +46735801268
Mathias Holm Pedersen

Mathias Holm Pedersen

Presskontakt Kommunikationschef, AstraZeneca Nordic +45 22937730

Om AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel för sjukdomar inom terapiområdena Onkologi, Sällsynta sjukdomar och Bioläkemedel, inklusive kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar (CVRM) samt Andningsvägar och Immunologi. AstraZeneca är baserat i Cambridge i Storbritannien och bedriver verksamhet i över 100 länder. Dess innovativa läkemedel används av miljontals patienter över hela världen.