Lupin Ltd announced that the US FDA has granted final approval for the company's abbreviated new drug application (ANDA) for trandolapril tablets, 1mg, 2mg and 4mg. Commercial shipments of the product have commenced.
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 approximately $49 million for the twelve months ended December 2006, based on IMS sales data.
"We are delighted with the timely approval of trandolapril tablets. This approval broadens our growing portfolio of cardiovascular medications," said Dr Kamal Sharma, managing director, of the company.