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AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Date:3/11/2010

WILMINGTON, Del., March 11 /PRNewswire-FirstCall/ -- On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT® (budesonide/formoterol fumarate dihydrate).

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"As we've witnessed over the past two days, there are many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA's question regarding LABA-containing products," said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca.  "AstraZeneca (NYSE: AZN) is confident in the positive benefit-risk profile of SYMBICORT in asthma as demonstrated by extensive clinical data and patient experience, and supports ongoing scientific discussion to address any outstanding questions regar
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