The pharmaceutical company GlaxoSmithKline said late Wednesday it would no longer seek approval to market its drug dutasteride (Avodart) for the prevention of prostate cancer. The company's announcement comes after a Food and Drug Administration advisory panel in January voted against expanding the drug's marketing approval to cover risk reduction for prostate cancer in high-risk men. Swedish authorities have also told the company they would not approve the new indication. The drug is approved for treating benign prostatic hyperplasia, a noncancerous enlargement of the prostate gland.
GlaxoSmithKline said it would withdraw applications for the new indication in all the countries where applications are currently pending. In countries where the application has been approved, the company said it would work with authorities to remove the indication from the product's license.
