pitavastatin

FDA Drug Profile — Pitavastatin Calcium

pitavastatin is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Pitavastatin Calcium. Available dosage form: tablet, film coated.

Drug Details

Generic Name
pitavastatin
Brand Names
Pitavastatin Calcium
Application Number
ANDA206070
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
3
Dosage Forms
TABLET, FILM COATED
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).