FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling

Friday, 9 March 2012 AstraZeneca today announced that on 7 March 2012, the FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that the FDA required AstraZeneca to include in the labelling for SEROQUEL® (quetiapine fumarate) and SEROQUEL XR® (quetiapine fumarate). AstraZeneca is evaluating the FDA’s decision and reasoning. NOTES TO EDITORS About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com CONTACTS Media Enquiries Esra Erkal-Paler +44 20 7604 8030 Investor Enquiries UK James Ward-Lilley +44 20 7604 8122 mob: +44 7785 432613 Karl Hård +44 20 7604 8123 mob: +44 7789 654364 Nicklas Westerholm +44 20 7604 8124 mob: +44 7585 404950 Investor Enquiries US Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043

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