Glenmark unit gets tentative approval from USFDA for Ezetimibe
Glenmark Generics Limited (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received tentative approval from the US Food and Drug Administration (FDA) for the generic version of cholesterol lowering drug Ezetimibe, which was sold under the brand name 'Zetia' in 10 mg strength.
It should be noted that, Glenmark had filed its Abbreviated New Drug Application with FDA seeking regulatory approval to market a generic version of Ezetimibe in 2006.
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 Jersy.
Glenmark's current portfolio consists of around 40 generic products authorized for distribution in the U. S. market. The Company currently has over 40 ANDA's filed with the U. S. FDA pending approval.
Glenmark Pharmaceuticals Ltd., the parent company of GGL, is a research-driven, global, fully integrated pharmaceutical company headquartered at Mumbai, India. It employs over 5000 people across its global operations across 80 countries.