1 introduction edwin l hemwall phd vice president worldwide regulatory & scientific affairs johnson merck consumer pharmaceuticals 2 nda 21 213 z nonprescription lovastatin 20 mg mevacor daily indication to help lower ldl bad cholesterol which may prevent a first heart attack 3 background july 2000 joint advisory committee review benefit of 10 dose not established statin otc safety generally accepted behavior needs further investigation august fda withdraws official guidance that discouraged development lowering drugs 4 present new paradigm and tested with input from academic experts increased per day treatment c goal primary prevention target population consistent ncep guidelines atp iii 2001 custom actual use study 3000 consumers evaluated option 1000 used for up 6 months comprehensive support program 5 key topics discussion today can an enable have greater role in the cardiovascular disease label eligibility criteria regard directions self management system healthcare professional
