Drug maker Glenmark Generics today said the firm's 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, the company said in a statement.
The company said it believes that as of date it has first-to-file status on the drug. Which 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," the company said.
Today's announcement is an important step in the evolution of Glenmark in the US. In the current financial year, the company has received six tentative approvals and six final approvals from FDA, Glenmark Generics Chief Executive Officer Terrance Coughlin said.
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.