Lupin gets USFDA nod for generic Avapro tablets

Lupin Pharmaceuticals has received approval for its Irbesartan tablets, used for treating hypertension, from US Food and Drugs Administration (USFDA) to market a generic version of Sanofi Aventis's Avapro tablets.

The tablets are available in 75-300 mg strengths and are the AB-rated generic equivalent of Sanofi Aventis's Avapro tablets, Lupin said in a statement issued here. Irbesartan is indicated for the treatment of hypertension and nephropathy in type II diabetic patients, it added. Avapro tablets had annual US sales of about USD 400.7 million in June, as per the IMS health sales data. Lupin is the fifth largest generics player in the US with 5.1 per cent market share by prescriptions. The company said it is also the fastest growing, top 10 pharma player in India, Japan and South Africa.