SCHERING/ORION FARESTON LAUNCH AWAITS RESOLUTION OF LABELING, PROMOTIONAL ISSUES; EUROPEAN TOREMIFENE REPORT CITES NEED FOR LONG-TERM TOXICITY STUDIES
Executive Summary
The launch date for Schering-Plough's Fareston is dependent on "satisfactory resolution" of discussions between FDA and the company regarding labeling and promotion, Schering indicated June 2. Schering will market Fareston in the U.S. under an exclusive agreement from Finland-based Orion Farmos, which submitted the NDA and received approval for the product on May 29. "Schering expects pricing to be comparable to that of Zeneca's Nolvadex (tamoxifen).