Glenmark Pharmaceuticals announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) to sell the generic version of Schering Plough and MSP Singapore Company LLC’s hypercholesterolemia treatment Zetia (ezetimibe) in the United States.
Glenmark, which has got sanction for 10-milligram tablets of the drug, is likely to get 180 days marketing exclusivity for the drug upon patent expiry.
Zetia recorded sales of $1.5 billion during the last year (2008), the drug maker said in a statement.