Merck/Schering-Plough Pharmaceuticals (MSP) announced that it has submitted to the US Food and Drug Administration (FDA) for standard review a New Drug Application (NDA) for Ezetimibe/Simvastatin tablet, an investigational cholesterol lowering medicine, as adjunctive to diet, for the reduction of elevated cholesterol levels (hypercholesterolemia).

The application was submitted on September 24, 2003 and is the second medicine that Merck/Schering-Plough Pharmaceuticals has submitted to the FDA. If no comments are received from the agency by Nov. 23, 2003, the application will be considered filed.

If accepted for filing and subsequently approved, Ezetimibe/Simvastatin would be the first product to reduce cholesterol through dual inhibition by targeting both cholesterol production in the liver and absorption in the intestine. Ezetimibe/Simvastatin is a single tablet that contains the active ingredients of the cholesterol-lowering drugs Zetia (ezetimibe), which inhibits cholesterol absorption, and Zocor (simvastatin), which reduces cholesterol production in the liver.

Approved by the FDA in October 2002, Zetia is the first in a class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol through a unique mechanism of action. Zetia is indicated for use either by itself or together with statins in patients with high cholesterol to reduce LDL "bad" cholesterol and total cholesterol. Zetia is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol. Zetia, along with diet, has been proven to significantly improve LDL cholesterol levels. Ezetimibe is also marketed globally, including the European Union and other international markets, under the name Ezetrol.

Zocor is marketed by Merck & Co., Inc. and is in the class of cholesterol lowering agents known as statins. Zocor is used along with diet to improve cholesterol levels in people with high-cholesterol, when diet alone is not enough. Zocor has been proven to significantly improve LDL and HDL cholesterol levels, as well as triglyceride levels.