ARTICLE | Clinical News

Proscar finasteride regulatory update

November 1, 2010 7:00 AM UTC

FDA's Oncologic Drugs Advisory Committee will meet on Dec. 1 to discuss sNDAs for Avodart dutasteride from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) and Proscar finasteride from Merck. GSK is seeking to expand the label for Avodart to include reduction in the risk of prostate cancer in men at increased risk. The 5-alpha reductase inhibitor is already approved to treat symptomatic benign prostatic hyperplasia (BPH). Proscar is also approved to treat symptomatic BPH, but Merck has not proposed to expand the label or disclosed future plans for the Type II 5-alpha reductase inhibitor. ...