Blueprint
FORM
6-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Report
of Foreign Issuer
Pursuant to Rule
13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of January 2017
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
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20-F X
Form
40-F __
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
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mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
Yes __ No
X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule
12g3-2(b): 82-_____________
26 January 2017 10:00
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.
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-SuspensionTM
Delivery 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.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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AstraZeneca PLC
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Date:
26 January 2017
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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