Lupin gets FDA for Trandolapril

New Delhi, June 14 (UNI) Domestic pharma company Lupin Ltd today announced that the US Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg.

Commercial shipments of the product have commenced, an official statement said.

''We are delighted with the timely approval of Trandolapril tablets. This approval broadens our growing portfolio of cardiovascular medications,''Lupin Ltd Managing Director Kamal Sharma said.

The company's Trandolapril tablets are the AB-rated generic equivalent of Abbott's Mavik tablets, indicated for the treatment of hypertension. The brand product had annual sales of 49 million dollar for the twelve months ended December 2006, based on IMS sales data.

UNI