Lupin gets tentative US FDA approval for Trandolapril

Mumbai, Dec 19 (UNI) Pharma major Lupin today announced that the US Food and Drugh Administration (FDA) has granted it's tentative approval for the company's new drug 'Trandolapril', which is used in the treatment of hypertension.

Lupin's Trandolapril Tablets will be the AB-rated generic equivalent of Abbott's Mavik Tablets.

Lupin intends to launch the generic version of the drug after gaining final approval from the FDA, which is expected upon the expiry of Abbott's Mavik Tablets patent protection for their brand product, in June 2007, their release said.

Annual product sales of these tablets in the US were approximately USD 53 million for the twelve months ended July 2006, according to an IMS data, the release added.

UNI AR WD AW1241