Glenmark receives US FDA nod for Ezetimibe

Drug firm Glenmark Generics Ltd today said it has received tentative approval from the US Food and Drug Administration (FDA) for the generic version of cholesterol lowering drug Ezetimibe, sold under the brand name 'Zetia' in 10 mg strength.      

Glenmark has got the tentative approval for the generic version of Schering Plough and MSP Singapore Company LLC's anti-cholesterol compound Ezetimibe, which has received sales of 1.5 billion dollars in 2008, the company said in a statement.     

The company believes that it is first to file status on Ezetimibe tablets and thereby it also has a potential of getting marketing exclusivity of 180 days in the US.      

However, the company said, product launch is dependent upon receipt of final approval from the FDA and is also dependent on the outcome of litigation currently pending in the US district court of New Jersey.      

Glenmark had filed its Abbreviated New Drug Application with FDA seeking regulatory approval to market a generic version of Ezetimibe in 2006.      

Glenmark Generics is a US-based subsidiary of Mumbai head quartered Glenmark Pharmaceuticals Ltd.