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Pharma major Lupin today said its subsidiary, Lupin Pharmaceuticals, has received approval for its Irbesartan tablets from the US Food and Drugs Administration (FDA) to market a generic version of Sanofi Aventis’s Avapro tablets.
Irbesartan tablets are available from 75 to 300 mg and are the AB-rated generic equivalent of Sanofi Aventis’s Avapro tablets, the company 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 $400.7 million in June, according to 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 pharmaceutical player in India, Japan and South Africa.
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