Published on November 20, 2004 at 7:48 PM
Patient safety is the number one priority at AstraZeneca. Companies and regulators have a duty to scrutinise all medicines closely.
In the case of Crestor (rosuvastatin calcium), the application for approval was the most extensive ever for a statin involving more than 12,000 patients, and was unanimously recommended for approval by the FDA's advisory board in July of 2003.
To date more than 45,000 patients have received Crestor in clinical trials, more than 12 million prescriptions have been written worldwide, and more than 3.5 million patients have been prescribed the drug. Based on these data, we are fully confident in the safety profile of Crestor, which has now been approved in more than 65 countries worldwide. Latest information on Crestor safety, as well as clinical data, updated as recently as last Friday, is available on www.rosuvastatininformation.com.
To date, the FDA has not given the company any indication of a major concern regarding Crestor, and the comments today are inconsistent with past public statements from the FDA and our understanding of its current view of the safety and efficacy of Crestor.
http://www.astrazeneca.com/