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news.US-based healthcare company AstraZeneca has announced that the FDA has granted an additional six-month period of exclusivity to market Casodex for its licensed advanced prostate cancer indication until April 1, 2009.
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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 50mg 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).