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Lupin receives US FDA tentative approval for generic Livalo tablets

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Lupin receives US FDA tentative approval for generic Livalo tablets

Mumbai Pharma major Lupin Limited (Lupin) announced today that it has received tentative approval for its Pitavastatin tablets, 1 mg, 2 mg and 4 mg for 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.
 

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Description

  • 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 has US sales of USD 245.3 million, according to IMS MAT September 2016.

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