FDAnews
www.fdanews.com/articles/62893-barr-launches-generic-actiq-cancer-pain-management-product

BARR LAUNCHES GENERIC ACTIQ CANCER PAIN MANAGEMENT PRODUCT

September 28, 2006

Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has launched a generic version of Cephalon Inc.'s ACTIQ (oral transmucosal fentanyl citrate) [C-II], 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg cancer pain management treatment product. Barr launched the product under the terms of a License Agreement previously granted to Barr by Cephalon in August 2004, pursuant to a Federal Trade Commission Order. The license grants Barr a non-exclusive right to sell a generic version of ACTIQ. Under the obligations of the agreement, Cephalon is currently supplying Barr with fentanyl citrate manufactured under Cephalon's New Drug Application (NDA), which Barr then has the right to sell and market. Barr's Abbreviated New Drug Application (ANDA) is currently under active review at the U.S. Food & Drug Administration (FDA).

PR Newswire (http://sev.prnewswire.com/health-care-hospitals/20060927/NYW03027092006-1.html)