Lupin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Irbesartan Tablets, 75 mg, 150 mg and 300 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Sanofi Aventis US, LLC’s (Sanofi Aventis) Avapro Tablets, 75 mg, 150 mg and 300 mg strengths.
Lupin’s Irbesartan Tablets, 75 mg, 150 mg and 300 mg 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 II diabetic patients.
The company has also received final approval for its oral contraceptive Kurvelo Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg from the (US FDA) to market a generic version of Teva Branded Pharmaceuticals (Teva) Nordette Tablets (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg.
Lupin’s Kurvelo tablets are the AB-rated generic equivalent of Teva’s Nordette tablets. Lupin’s Kurvelo tablets is a Levonorgestrel and Ethinyl estradiol combined oral contraceptive indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Lupin is marketing its Kurvelo tablets in 21 light orange colored active tablets containing 0.15 mg Levonorgestrel and 0.03 mg Ethinyl estradiol and seven pink inert tablets (without hormones). This dosage regimen is identical to that of Nordette.
EP News Bureau
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