/ Lupin Receives Tentative Approval For Generic LivaloTablets ~ Ways2Capital|Stock Tips|Stock Market Tips|Intraday Stock Tips|Stock Trading Tips|NSE BSE Tips

Saturday, 31 December 2016


Pharma Major Lupin Limited (Lupin) has received tentative approval for its Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg from the United States Food and Drug Administration (FDA) to market a generic version of Kowa Company Limited's (Kowa) Livalo Tablets 1 mg, 2 mg, and 4 mg. The filing is from Lupin's Pithampur (Indore) manufacturing facility.

Lupin's Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg are the AB rated generic equivalent of Kowa's Livalo Tablets, 1 mg, 2 mg, and 4 mg. Pitavastatin Tablets are indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Livalo Tablets had US sales of USD 245.3 million (IMS MAT Sep 2016).
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