Canada first market for Crestor

pharmafile | October 27, 2003 | News story | |   

AstraZeneca's Crestor is to receive an immediate launch in its first market after Canada's regulator's approved the new cholesterol lowering drug.

The product has already been approved in the Netherlands, and is due for launch across Europe in the second half of 2003, but requests for further data from the US have undermined analysts' confidence in the drug's blockbuster potential.

The company has now submitted the extra clinical trial data to the FDA, and now hopes to see its 'approvable' status in the US gain final confirmation by the end of the year.

Doubts about the safety of Crestor were confirmed last year when AstraZeneca said it was dropping high doses because of side-effects, but insisted that normal dosage was unaffected.

Crestor has already been approved in Singapore, and is also awaiting approval in Japan and other markets.

The global statin market is estimated to be worth $18 billion and is growing at approximately 20% a year.

Related Content

No items found

Latest content