AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old

Monday, 6 April 2009 AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for SYMBICORT (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler (pMDI) for the long-term maintenance treatment of asthma in paediatric patients ages 6-11 years. The FDA stated that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the individual components of SYMBICORT – budesonide and formoterol – and to establish how the individual components contribute to the combination product, in paediatric patients ages 6-11 years. AstraZeneca is evaluating the CRL and will provide a response to the Agency in due course. SYMBICORT was approved in the US in July 2006 for the long-term maintenance treatment of asthma in patients 12 years of age and older and in February 2009 for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The CRL has no impact on the current prescribing information for the treatment of patients taking SYMBICORT for approved indications in asthma and COPD. NOTES TO EDITORS: About SYMBICORT In the US, SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. Administered twice daily, SYMBICORT is a combination of two proven respiratory medications – budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). SYMBICORT 160/4.5 mcg is also indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg two inhalations twice daily. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com CONTACTS: Media Enquiries: Neil McCrae +44 207 304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 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 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-25396 Date of next review: August 2022 Resources All resources Open Innovation Externally sponsored scientific research Medical Information for HCPs US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement AZethics – Report A Concern Supplier information Social Media Community Guidelines Social Media LinkedIn Twitter YouTube Instagram Glassdoor Facebook utility links Legal notice and Terms of Use Privacy notice Site map Contact us Cookie policy © AstraZeneca 2021 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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