Glenmark arm gets tentative USFDA nod
April 28, 2009 – 12:21 am | 3 views
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Glenmark Pharmaceuticals announced that its subsidiary company Glenmark Generics has received tentative approval from US Food and Drug Administration (USFDA) for cholesterol-lowering agent Ezetimibe.
Ezetimibe is the generic version of Schering Plough and MSP Singapore Company LLC`s hypercholesterolemia treatment Zetia.
The USFDA has granted the tentative approval for 10 mg tablets. This constitutes the first tentative approval granted by USFDA for a generic version of the drug. Glenmark believes that it has first-to-file status on Ezetimibe tablets, thereby providing a potential of 180-days of marketing exclusivity.
Glenmark would have the earliest opportunity among any competitors to gain market share from the branded product Zetia which achieved sales of USD 1.5 billion of 2008. Product launch of these tablets is dependent upon receipt of final approval of its Abbreviated New Drug Approval (ANDA) from the US FDA and resolution of litigation currently pending in the US district court of New Jersey.
The company will be vertically integrated by manufacturing the active pharmaceutical ingredient for its Ezetimibe tablets.
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