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pitavastatin calcium

FDA Drug Profile — Pitavastatin, pitavastatin calcium, Livalo

Drug Details

Generic Name
pitavastatin calcium
Brand Names
Pitavastatin, pitavastatin calcium, Livalo
Application Number
ANDA205932
Sponsor
AvKARE
NDC Codes
23
Dosage Forms
TABLET, FILM COATED, TABLET
Routes
ORAL
Active Ingredients
PITAVASTATIN CALCIUM

Indications and Usage

1 INDICATIONS AND USAGE Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin tablets are a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: ( 1 ) • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).