New cholesterol combo
Executive Summary
Kos' Advicor (niacin/lovastatin) combination receives "approvable" letter from FDA July 20 after a 10-month review. Kos is seeking an indication for treatment of primary hypercholesteremia and mixed dyslipidemia for patients requiring more lipid modification than either of the components alone. Full approval awaits expiration of the six-month pediatric exclusivity granted to Merck's Mevacor (lovastatin), which expires Dec. 15, as well as completion of FDA's inspection of Miami-based Kos' manufacturing facility