Casodex gains extra time in US
This article was originally published in Scrip
As a result of data collected in paediatric patients, the US FDAhas granted AstraZenecaan additional six-month period of exclusivity for its anticancer Casodex (bicalutamide). The extension relates to the only Orange Book-listed patent covering the product (the '505 patent), set to expire on October 1st, 2008, but now extended to April 1st, 2009. The company said that it has been working with the FDA in the investigation of Casodex in the paediatric setting, but would not be seeking an indication in this population.
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