The approval was expected -- an advisory panel gave the drug a green light in early July -- but the stock did move on the news, up $1.32, or 3.2%, to $42.22 in after-hours trading, after gaining 60 cents during the regular session.
Crestor will compete with similar drugs, called statins, including
Estimates for sales of the drug range as high as $5 billion.
"We are delighted with the approval of Crestor in the United States," AstraZeneca CEO Tom McKillop said in a prepared statement. "We believe that Crestor offers an important new treatment option for millions of patients."
AstraZeneca said the clinical development program for Crestor is the largest preapproval program ever submitted to evaluate the safety and efficacy of a new statin. More than 12,500 patients are included in the safety database, with more than 4,000 patients receiving the 40-milligram dose.
The company licensed the worldwide rights to Crestor from Japanese pharmaceutical company
Shionogi & Co.
The drug was first approved in the Netherlands in 2002. Since then, 23 other countries have cleared the product.