Anglo-Swedish drug major AstraZeneca says that the US Food and Drug Administration has granted an additional six-month pediatric period of exclusivity to market Arimidex (anastrozole) for its licensed breast cancer indications until June 2010. Prior to this pediatric extension, the last patent was due to expire in December 2009.
John Patterson, executive director of development at AstraZeneca, said "preclinical and clinical data supported the investigation of the therapeutic potential of Arimidex in pediatric conditions that manifest symptoms resulting from increased estrogen production, for example: gynecomastia in pubertal boys and precocious puberty in girls with McCune-Albright Syndrome." He added that AstraZeneca will not be seeking an indication in either of these pediatric conditions based on trial results.
...and Nexium gets pediatric use approval in Sweden
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