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FDA Panel Backs AstraZeneca’s Crestor

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From Reuters

AstraZeneca’s cholesterol-lowering drug Crestor got unanimous backing from a U.S. advisory panel, clearing a major hurdle for the company’s biggest new drug hope.

The Food and Drug Administration panel voted 9 to 0 to recommend that the agency approve doses ranging from 5 to 40 milligrams. The FDA usually follows its panels’ advice.

Analysts have said Crestor’s peak sales may hit $3 billion worldwide. The FDA is expected to make a decision by Aug. 12, the company said.

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Crestor already is marketed in Canada and parts of Europe, but U.S. approval was delayed after regulators asked for more information.

Shares of AstraZeneca closed up 66 cents at $42.56 on the New York Stock Exchange.

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