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www.fdanews.com/articles/61126-astrazeneca-receives-fda-approval-for-symbicort

ASTRAZENECA RECEIVES FDA APPROVAL FOR SYMBICORT

July 24, 2006

AstraZeneca has won approval from the FDA for its asthma drug Symbicort, but the company said that it would not sell it in the United States until mid-2007.

The approval could be a blow for the rival drugmaker GlaxoSmithKline, which makes the asthma drug Advair, its top-selling product.

Symbicort has been sold in Europe for more than five years, but getting it in the United States market has been a long process.

AstraZeneca said it had not started selling Symbicort immediately because it wanted to show that the drug had a shelf life of at least 18 months. At the moment, the company has only enough data to prove 12 months.