Lupin gets FDA nod for generic of Sanofi's BP drug

Mumbai: Lupin's subsidiary, Lupin Pharmaceuticals, received final approval from the US Food and Drugs Administration (FDA) to market Irbesartan tablets, 75 mg, 150 mg and 300 mg, which is the generic version of Sanofi Aventis' Avapro tablets, 75 mg, 150 mg and 300 mg.

Lupin's Irbesartan tablets, 75 mg, 150 mg and 300 mg are the AB-rated generic equivalent of Avapro. Irbesartan is an angiotensin II receptor antagonist and is indicated for the treatment of hypertension and nephropathy in type 2 diabetic patients.

Avapro is estimated to have clocked annual sales of approximately $400.7 million in the US alone, according to IMS MAT Jun 2012 data.