Lupin’s subsidiary receives USFDA approval for generic Avapro Tablets

17 Oct 2012 Evaluate

Lupin’s subsidiary - Lupin Pharmaceuticals Inc. has received final approval for its Irbesartan Tablets 75mg, 150mg and 300mg from the United States Food and Drugs Administration (USFDA) to market a generic version of Sanofi Aventis US, LLC’s (Sanofi Aventis) Avapro Tablets, 75mg, 150mg and 300mg strengths.

Lupin’s Irbesartan Tablets 75mg, 150mg and 300mg are the AB-rated generic equivalent of Sanofi Aventis’s Avapro Tablets. Irbesartan is an angiotensin II receptor antagonist and is indicated for the treatment of Hypertension and Nephropathy in Type 2 Diabetic patients. Avapro Tablets had annual US sales of approximately $400.7 million (IMS MAT June 2012 sales).

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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