GSK withdraws regulatory application for additional use of Avodart
LONDON British drug maker GlaxoSmithKline is temporarily withdrawing its regulatory approval application seeking an additional use for an enlarged prostate treatment in order to update it, the company announced Monday.
The company is seeking approval from the Food and Drug Administration of Avodart (dutasteride) for prostate cancer risk reduction in men who have increased risk of developing the disease. The drug is currently approved for treating enlarged prostate.
GSK did not specify what it would add to the application, but said the updates were not related to new safety or efficacy findings and that it would resubmit the application “shortly.”