KENILWORTH, NJ (March 22, 2004) — Schering-Plough Corp., here, and Merck & Co., Inc., Whitehouse Station, NJ, announced last week that ezetimibe/simvastatin tablets have received marketing approval in Mexico for the treatment of elevated cholesterol levels (hypercholesterolemia).
The approval in Mexico represents the first approval of a product that achieves dual inhibition of two sources of cholesterol by inhibiting both cholesterol production in the liver and cholesterol absorption in the intestine, according to Schering-Plough.
Ezetimibe/simvastatin contains the active ingredients of the cholesterol-lowering drugs ezetimibe, which inhibits cholesterol absorption in the intestine, and simvastatin, which reduces cholesterol production in the liver, the company said.
Zetia is the United States trade name for ezetimibe, which is marketed and sold in the U.S. by Merck/Schering-Plough Pharmaceuticals, a joint venture between the two companies. Simvastatin is marketed by Merck under the trade name Zocor.
In the U.S., a new drug application for Vytorin (ezetimibe/simvastatin) was submitted on Sept. 24, 2003, Schering-Plough said. The filing was accepted by the U.S. Food & Drug Administration on Nov. 23, 2003, and is currently under standard review.
In Mexico, ezetimibe/simvastatin will be available in several dosing strengths combining ezetimibe with simvastatin 10/10mg, 10/20mg, 10/40mg or 10/80mg and is expected to be launched next month.
