By KATHY SANDLER and ELENA BERTON
LONDON -- AstraZeneca PLC Monday said the U.S. Food and Drug Administration has asked for more information on asthma drug Symbicort before it can allow the use of the inhaler in small children.
The FDA's complete response letter said data provided by the company was inadequate to establish the appropriate dose of the two components of Symbicort, budesonide and formoterol, for patients aged between six years old and 11 years old.
The drug was approved in 2006 in the U.S., where it competes against GlaxoSmithKline PLC's asthma blockbuster Advair for patients over 12 years old for the long-term treatment of asthma. It also is approved for treatment of patients with chronic diseases such as emphysema.
AstraZeneca said the letter will have no impact on current prescribing of the drug to these patients.
It added it is evaluating the complete response letter and will provide a response to the FDA in due course.
Symbicort in 2008 was AstraZeneca's fourth largest-selling product, with sales rising 22% to $2 billion.
Matrix Corporate Capital analyst Navid Malik said the FDA's stance could compound negative sentiment from last week, when the U.S. regulator expressed concern about allowing expanded use of AstraZeneca's antipsychotic drug, Seroquel.
Mr. Malik noted that U.S. sales of Symbicort have already been disappointing, so this delay "won't help."
In a separate statement, AstraZeneca said that the sale of its portfolio of over-the-counter products to rival GlaxoSmithKline has been cleared by Swedish competition authorities.
AstraZeneca will receive around $220 million from the sale, which was announced in November last year.
Write to Kathy Sandler at kathy.sandler@dowjones.com and Elena Berton at elena.berton@dowjones.com
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