FDA identified 20 Rx drugs and biologics that must have an approved risk evaluation and mitigation strategy, including GlaxoSmith-Kline’s Lotronex, Novartis’ Clozaril, Cephalon’s Actiq, Hoffmann-LaRoche’s Accutane, Celgene’s Revlimid and Thalomid, Danco’s Mifeprex and Biogen Idec’s Tysabri.