FDA Approves Generic Casodex (Bicalutamide) for Prostate Cancer

India-based drug maker Sun Pharmaceuticals Industries Ltd said today it has been given U.S. Food and Drug Administration approval to market generic versions of the prostate cancer drug Casodex.

Casodex, known generically as bicalutamide, is made by AstraZeneca PLC and is administered in tablet form. The drug is an anti-androgen that prevents the actions of male hormones, called androgens, to stops the production of testosterone. Casodex is used along with another hormone drug, called a luteinizing hormone-releasing hormone, as a therapy for prostate cancer.

Casodex earned annual sales of about $314 million in the United States, officials said.

Sun Pharmaceuticals said the company will sell bicalutamide tablets in 50-milligram doses to be taken once daily.

Generic versions of drugs generally are cheaper than brand-name drugs, so news that Sun Pharmaceuticals soon will launch generic bicalutamide tablets should be welcome news to prostate cancer patients who take Casodex.

Prostate cancer is among the most commonly diagnosed forms of the disease among Americans. More than 185,000 men developed the cancer and nearly 29,000 people died from prostate cancer in 2005, according to the American Cancer Society.

Prostate cancer is the leading form of cancer among American men and a leading cause of death among men.

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