Lupin receives final FDA Approval for Trandolapril

Mumbai, Jun 14: Mumbai based leading pharmaceutical company, Lupin Ltd today 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 and commercial shipments of the product have commenced.

Lupin'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 USD 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 Lupin Managing Director Dr. Kamal Sharma, in a statement issued here today.

Reacting to the announcement, Lupin's shares rose by 1.65 per cent and quoted at Rs 683.90 at the Bombay Stock Exchange.

UNI