Merck resubmits cholesterol combo pill to FDA
Merck & Co. said Wednesday it has resubmitted its application for a new combination cholesterol drug to the Food and Drug Administration, which rejected the experimental medication in March.
The drugmaker is seeking approval for a pill that combines a generic version of Lipitor, the top-selling drug of all time, with Merck's cholesterol medicine Zetia. The company said in a statement that the FDA judged the drug application complete and ready for review. A decision is expected in the first half of 2013.
Merck's experimental drug, still known only as MK-0653C, contains medicines that fight high cholesterol in two different ways to reduce risk of heart attack and stroke.
Lipitor, known chemically as atorvastatin, is part of the widely used class of drugs called statins that reduce the amount of cholesterol naturally produced in the liver. Zetia, on the other hand, reduces the amount of cholesterol absorbed from the food the patient eats.
Merck shares rose 40 cents to close at $41.34 in trading Wednesday.