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AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)
Date:12/11/2008

LONDON, Dec. 11 /PRNewswire-FirstCall/ -- On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded that the benefits of AstraZeneca's SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), a combination LABA/Inhaled Corticosteroid (ICS) medication, outweigh the risks in adult and adolescent asthma patients.

Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said, "The safety and efficacy of SYMBICORT have been demonstrated in numerous clinical trials and from extensive post-marketing use around the world. We are pleased that the joint advisory committees' recommendation confirms our view on the positive benefit-risk profile of SYMBICORT."

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency usually takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

About SYMBICORT in the U.S.

SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) is approved in over 100 countries for the long-term maintenance treatment of asthma and is available in two different inhalers, SYMBICORT TURBUHALER and in the U.S. as SYMBICORT pMDI.

SYMBICORT is a combination therapy indicated in the U.S. for the long-term maintenance treatment of asthma in patients 12 years of age and older. SYMBICORT should not be used in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of
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SOURCE AstraZeneca
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