Lupin gets tentative USFDA approval for hypertension drug

New Delhi, Dec 19 (UNI) Lupin Ltd today said it has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Trandolapril tablets, from the United States Food and Drug Authority (USFDA).

The approval has been received for marketing of 1mg, 2mg and 4mg of the drug used for the treatment of hypertension.

The company's Trandolapril tablets will be AR-rated generic, equivalent of Abbott's Mavik tablets. According to data provided by IMS, the annual sales of the tablets in the US was 53 million dollars for the 12 months ended July 2006.

The company intends to launch the generic on final approval which is expected up on expiry of patent protection for the brand product in June 2007.

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