AstraZeneca Plc announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market Casodex (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009.

AstraZeneca has been working with the FDA in the investigation of the safety and effectiveness of Casodex in a pediatric setting but will not be seeking an indication in this population.

Casodex is currently approved in the US at a dose of 50 mg daily tablet for use in combination with a luteinizing hormone-releasing hormone analog (LHRH-A) for the treatment of advanced prostate cancer (metastatic Stage D2).

Over 186,000 men will be diagnosed with prostate cancer in the U.S. in 2008, making it the most frequently diagnosed cancer in men. After lung cancer, prostate cancer is the second leading cause of cancer death in men, with an estimated 28,660 deaths in 2008. One in six men will develop prostate cancer in his lifetime.

First half sales of the drug were $ 674 million.