prostate-report.org

GlaxoSmithKline withdraws its application for new drug use

The world’s No. 2 drugmaker, British company GlaxoSmithKline PLC, announced Monday it is temporarily withdrawing its application for U.S. approval of a drug to prevent prostate cancer. GlaxoSmithKline said it wants to provide an update to its application to the Food and Drug Administration. Those applications generally include thousands of pages of data on testing results and characteristics of an experimental drug. The company said it expects to resubmit its application to the FDA shortly.

The drug is already sold under the name Avodart, for treating symptoms of an enlarged prostate. The company was seeking approval for a new use, reducing risk of prostate cancer, after research showed Avodart could reduce that risk by about 25 percent.