Dutasteride application for PCa prevention withdrawn; will be resubmitted

December 17, 2009

GlaxoSmithKline has announced that in order to provide an update to the application, the company is withdrawing its supplemental new drug application for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

GlaxoSmithKline has announced that in order to provide an update to the application, the company is withdrawing its supplemental new drug application for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

This action is not the result of new findings related to safety or efficacy, GlaxoSmithKline said in a statement, and the company expects to resubmit the file in the near future.