Lupin gets USFDA approval for Pitavastatin tablets

New Delhi, Dec 30 (IANS) Pharmaceutical major Lupin on Friday said it has received tentative approval for its cholesterol lowering Pitavastatin tablets from the US Food and Drug Administration (USFDA).

“Pharma Major Lupin announced today that it 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 pharmaceutical company said in a regulatory filing to the BSE.

“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,” it added.