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AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA
Date:9/22/2008

WILMINGTON, Del., Sept. 22 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (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).

AstraZeneca has a well-established prostate cancer portfolio including hormonal treatments CASODEX, launched in 1995, and ZOLADEX(R) (goserelin acetate implant), launched in 1989. Three Phase III clinical research trials (ENTHUSE program) are currently underway to evaluate the safety and effectiveness of an investigational compound, ZD4054, in non-metastatic and metastatic hormone-resistant prostate cancer.

About Prostate Cancer

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.(1) After lung cancer, prostate cancer is the second leading cause of cancer death in men, with an estimated 28,660 deaths in 2008.(2) One in six men will develop prostate cancer in his lifetime.

About CASODEX(R) (bicalutamide) Tablets

CASODEX at a dose of 50 mg daily is a prescription medication approved for use in combination with an injection of a luteinizing hormone-releasing hormone analog (LHRH-A) for treatment of advanced prostate cancer (metastatic Stage D2).

CASODEX at a dose of 150 mg daily is not approved for use alone or with other treatments. See full Prescribing Information under the section on "CLINICAL PHARMACOLOGY-Clinical Studies-Safet
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SOURCE AstraZeneca
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