Bristol-Myers Squibb Company intends to pursue US FDA approval for an over-the-counter (OTC) version of Pravachol (pravastatin sodium) 20 mg as a cholesterol-lowering treatment option in the United States. Pravachol is approved in the United States only as a prescription drug, the company announced here.
BMS also said that it had entered into an agreement with Bayer HealthCare LLC for Bayer's Consumer Care Division to handle OTC sales and marketing for pravastatin 20 mg in the United States, should the FDA approve OTC use of the drug. Bayer was selected given its experience in the cardiovascular category and the leadership position it has achieved in the marketing of the Bayer Aspirin brand.
Pravachol (pravastatin sodium), a prescription drug, is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough.