Chemistry and Industry - FDA approves Crestor for AZ
AstraZeneca’s second-generation cholesterol drug, Crestor, has finally been approved by the US Food and Drug Administration (FDA).
The drug, which is seen as a key product for the company, has been approved at all doses, and without the kidney testing requirements that many were expecting for higher doses.
The drug has faced delays and safety concerns following the withdrawal of Bayer’s similar drug. Baycol, in 2001. An FDA advisory committee recommended that patients taking the largest dose should have regular kidney check-ups to identify possible side-effects, but this was not a condition of approval.
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Analysts at Credit Suisse First Boston expect the drug to hit peak sales of $3.4bn/year in 2007.
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