Six-month pediatric extension for AstraZeneca's Casodex
The US Food and Drug Administration has granted an additional six-month period of exclusivity to market Casodex (bicalutamide) for its licensed advanced prostate cancer indication until April 1, 2009. Anglo-Swedish drug major AstraZeneca says it has been working with the FDA in the investigation of the safety and effectiveness of its product in a pediatric setting but will not be seeking an indication in this population.
Casodex is currently approved in the USA at a dose of 50mg daily tablet for use in combination with a luteinizing hormone-releasing hormone analog for the treatment of advanced prostate cancer (metastatic Stage D2).
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