Pitavastatin Magnesium

FDA Drug Profile — ZYPITAMAG

Drug Details

Generic Name
Pitavastatin Magnesium
Brand Names
ZYPITAMAG
Application Number
NDA208379
Sponsor
Zydus Lifesciences Limited
NDC Codes
5
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
PITAVASTATIN, PITAVASTATIN MAGNESIUM

Indications and Usage

1 INDICATIONS AND USAGE ZYPITAMAG is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Pediatric use information is approved for Kowa Co Ltd LIVALO (pitavastatin) tablets. However, due to Kowa Co Ltd marketing exclusivity rights, this drug product is not labeled with that information. ZYPITAMAG is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1 ).