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.
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.