First launch, in Canada, for AstraZeneca's superstatin Crestor

AstraZeneca has been granted approval by Health Canada for itsnew-generation statin drug Crestor (rosuvastatin) and will launch it immediately. Crestor has been approved across its 10mg-40mg dose range for the management of primary hypercholesterolemia, mixed dyslipidemia and familial hypercholesterolemia in Canada, which has an annual statin market valued at C$1 billion ($657 million) that is growing 20% a year.

Crestor received its first marketing approval in the Netherlands last year and, ahead of an introduction in the European Union, entered the Mutual Recognition Procedure. Approvals in other EU member states should take place in the first half of this year. AstraZeneca notes that the drug has also been approved in Singapore.

The company appears to have turned the corner with Crestor after a bumpy ride over the last few months, during which the US Food and Drug Administration issued an approvable letter for the drug but asked for more data to back up its safety at the high end of its dose range. The company has just submitted new clinical data that, it believes, should satisfy the agency's requirements and put Crestor back on track for US approval in the second half of this year (Marketletter February 17).