AstraZeneca announced that the US Food and Drug Administration (FDA) confirmed that Crestor will be reviewed by the FDA's Endocrinologic and Metabolic Advisory Committee on July 9, 2003. AstraZeneca is confident in the regulatory package submitted for Crestor and looks forward to presenting its safety and efficacy data from the extensive clinical trial programme.
Crestor was first approved in the Netherlands in 2002 and has now successfully completed the Mutual Recognition Procedure in 13 other European countries. Crestor is awaiting approval in the US, Japan and other markets. Launches in Canada, the Netherlands and the UK have occurred, and further launches are scheduled, following national marketing authorizations and pricing and reimbursement discussions.