FDA Approves AstraZeneca Drug

AstraZeneca won Food and Drug Administration approval of its Crestor cholesterol-lowering drug, increasing competition for the world’s top-selling medicine, Pfizer Inc.’s Lipitor.

AstraZeneca is readying a marketing campaign for Crestor that some estimate will cost about $1 billion. Crestor worked better than other cholesterol drugs in some tests, and London-based AstraZeneca will stress this as Crestor competes with drugs that doctors already know well, analysts said.

With U.S. approval, Crestor’s annual sales may surpass $3 billion by 2007, making it the most important new product for AstraZeneca, analysts said.

The FDA approval had been widely expected after an advisory committee last month recommended the drug. But there had been concerns about the drug’s label as the committee voiced concern about possible kidney side effects with the 40-milligram dose.

Crestor’s label urges doctors to watch for elevated protein levels in the urine during routine testing of patients taking the 40-milligram dose.

AstraZeneca’s shares rose 60 cents to $40.90 on the New York Stock Exchange.