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AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA

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-Safety Data from Clinical Studies using CASODEX 150 mg" for additional important safety information regarding CASODEX 150 mg.

Important Safety Information about CASODEX

There have been reports of liver function problems during treatment with CASODEX. Therefore, your doctor will monitor your liver function with a blood test before you start treatment with CASODEX, at regular intervals during the first 4 months of treatment, and at regular times after that.

The most common side effects that occurred during treatment with CASODEX plus an injection of an LHRH-A were hot flashes (53%), pain (21% to 35%, including pelvic, back, and general), weakness (22%), and constipation (22%). Other side effects (reported in 12% to 18% of patients) were urination at night, blood in urine, diarrhea, swelling, shortness of breath, nausea, and infection.

For more information about CASODEX, including full Prescribing Information please visit

About ZOLADEX(R) (goserelin acetate implant)

ZOLADEX 3.6 mg depot and 10.8 mg depot are prescription medications approved for use in combination with flutamide (an antiandrogen) plus radiotherapy for locally advanced prostate cancer. Treatment with the combination should start 8 weeks prior to starting and continue during radiation therapy.

ZOLADEX 3.6 mg depot and 10.8 mg depot are also approved to use alone for patients with advanced prostate cancer. ZOLADEX may help reduce the size of the cancer and reduce symptoms (palliative treatment).

Important Safety Information about ZOLADEX

ZOLADEX, like other luteinizing hormone-releasing hormone analogs (LHRH-As), may cause an initial rise in testosterone. When used alone, there may be a temporary worsening of prostate cancer symptoms at the start of therapy.

Common side effects that occurred during treatment with ZOLADEX (goserelin acetate implant) plus flutamide and radiation therapy or ZOLADEX alone included hot flashes, decrease in sexual desire and/or ability to have erections, diarrhea, pain (general, pelvic, and bone), lower urinary tract symptoms, fatigue, nausea, breast growth, swelling, rash, upper respiratory infection, and sweating.

For more information about ZOLADEX, including full Prescribing Information for ZOLADEX 3.6 mg Depot and ZOLADEX 10.8 mg Depot visit

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information visit:

(1) Cancer Facts & Figures 2008. American Cancer Society publication. 008 .asp. Accessed July 8, 2008.

(2) Cancer Facts & Figures 2008. American Cancer Society publication. 008 .asp. Accessed July 8, 2008.

(Due to the length of these URLs, please copy and paste into your browser.)

SOURCE AstraZeneca
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