Glenmark gets USFDA nod for anti-hypertension drug

25 Jan 2010 Evaluate

Drug maker Glenmark Generics US-based subsidiary has got tentative approval from the US Food and Drug Administration (FDA) for drugs used in the treatment of hypertension. The trandolapril and verapamil hydrochloride extended release tablets are the generic version of Abbott's Tarka tablets, which has reported sales worth 64 million dollars for the 12 month period ended on September. It believes that as of date it has first-to-file status on the drug. This makes the company eligible for 180 days of generic marketing exclusivity.

Product launch is dependent upon receipt of final approval of Glenmark's Abbreviated New Drug Application (ANDA) from the USFDA and resolution of litigation currently pending in the US District Court for the District of New Jersey. In the current financial year, the company has received six tentative approvals and six final approvals from FDA. Glenmark’s current marketing portfolio consists of 49 products authorised for distribution in US and it has around 50 ANDAs in various stages of the approval with the USFDA.

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