FDA advisory panel gives Crestor thumbs up. (News).(the FDA advisory committee recommends the approval of AstraZeneca's Crestor)(Brief Article)

Chemical Market Reporter, July, 2003

THE FINISH LINE is in sight for AstraZeneca's Crestor (rosuvastatin), which was recommended for approval by a Food and Drug Administration (FDA) advisory committee. A critical product for the company, Crestor has had a turbulent path to marketing approval in the US. Crestor has already been launched in several markets in Europe, but US marketing efforts were stalled when the FDA issued an "approvable" letter for the statin in June 2002.

The agency, exercising caution after the debacle involving Bayer's statin Baycol (cerivastatin), was concerned about the safety profile of the 80 mg dose of Crestor and asked for more studies. Last week, the FDA panel recommended approval for up to the maximum dosage of 40 mg AstraZeneca withdrew the 80 mg portion of...

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