AstraZeneca applies to FDA to expand age group for Symbicort


WILMINGTON, Del. AstraZeneca has submitted a supplemental application to the Food and Drug Administration for approval of a new indication of its asthma-management drug Symbicort, the company announced Wednesday.

The drug has already been approved for use in children age 12 and older, but a study comprising five phase III trials of 1,446 children age 6 to 11, using pressurized metered-dose inhalers of Symbicort, found it to be as safe as dry-powder inhalers. The children in the study had previously used corticosteroid inhalers.

Sales of Symbicort reached $1.575 billion in 2007, according to AstraZeneca’s annual report.

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