FDA Approves Trandolapril Tablets

Armen Hareyan's picture

U.S. Food and Drug Administration has granted final approval for Lupin Pharmaceuticals's Abbreviated New Drug Application for Trandolapril Tablets, 1mg, 2mg and 4mg.

Commercial shipments of Trandolapril tablets have commenced.


Lupin's Trandolapril Tablets are the AB-rated generic equivalent of Abbott's Mavik(R) 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.

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "We are delighted with the timely approval of Trandolapril tablets." Ms. Gupta added, "This approval broadens our growing portfolio of cardiovascular medications, and we look forward to offering this cost-effective alternative to patients in the U.S."

Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.