19 October 2012 | Regulatory | By BioSpectrum Bureau
Lupin gets FDA nod for generic of Sanofi's BP drug
Good news for high blood pressure patients: Lupin gets FDA approval to market generic of Sanofi Aventis' Avapro
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.