Lupin Ltd has announced that the US FDA has granted tentative approval for the company's Abbreviated New Drug Application (ANDA) for Trandolapril tablets, 1mg, 2mg and 4mg.
Trandolapril is indicated for the treatment of hypertension.
The Company's Trandolapril tablets will be the AR-rated generic equivalent of Abbott's Mavik tablets. Annual product sales in the US of the tablets were approximately $53 million for the twelve months ended July 2006, based on IMS data.
The company intends to launch the generic on final approval, which is expected upon expiry of patent protection for the brand product in June 2007.