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2017-01-26

AstraZeneca: Symbicort granted paediatric exclusivity in the US

AstraZeneca today announced that on 25 January 2017 the US Food and
Drug Administration (FDA) granted six months of paediatric
exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol.

The FDA's decision was based on the evaluation of trials conducted in
children with asthma aged six up to 12 years in response to a Written
Request (a prerequisite for qualifying for paediatric exclusivity
under Section 505A of the Federal Food, Drug, and Cosmetic Act).
Symbicort is currently approved in the US to treat asthma in patients
12 years and older and for the maintenance treatment of Chronic
Obstructive Pulmonary Disease (COPD) in adults.

- ENDS -

NOTES TO EDITORS

About Symbicort

Symbicort is a combination formulation containing budesonide, an
inhaled corticosteroid (ICS), and formoterol, a long-acting
beta2-agonist bronchodilator (LABA), in a single inhaler. Symbicort
was first launched in Sweden in 2000 and has been approved in
approximately 120 countries to treat asthma and/or COPD either as
Symbicort Turbuhaler or Symbicort pMDI (pressurised metered-dose
inhaler).

Symbicort Inhalation Aerosol (pMDI) was first approved by the FDA in
the US in July 2006 for the treatment of asthma in patients 12 years
of age and older.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca's main therapy areas, and we
have a growing portfolio of medicines that reached more than 17
million patients in 2015. Our aim is to transform asthma and COPD
treatment through inhaled combinations at the core of care, biologics
for the unmet needs of specific patient populations, and scientific
advancements in disease modification. We are building on a 40-year
heritage in respiratory disease, and our capability in inhalation
technology spans both pressurised metered-dose inhalers (pMDIs) and
dry powder inhalers (DPIs), as well as our innovative
Co-SuspensionTMDelivery Technology. Our research is focused on four
key biological pathways: eosinophilic disease, Th2-driven disease,
epithelial-driven pathobiology and autoimmunity.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. 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 and follow us on Twitter @AstraZeneca.

Media Enquiries
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Burrows
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Investor
Relations
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Larsen
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Income, M&A
Henry Wheeler Oncology +44 203 749 5797
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Diseases
Nick Stone Respiratory +44 203 749 5716
US toll free +1 866 381 7277

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