What is the generic name?

ROSUVASTATIN

What is the Trade Name for ROSUVASTATIN?

EZALLOR SPRINKLE

What are the Indications for ROSUVASTATIN?

• 1 INDICATIONS AND USAGE Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca‚Äôs CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca‚Äôs marketing exclusivity rights, this drug product is not labeled with that pediatric information. EZALLOR Sprinkle is an HMG Co-A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.1) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.2) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB (1.3) Limitations of use (1.4): EZALLOR Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias 1.1 Hypertriglyceridemia EZALLOR Sprinkle is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.2 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) EZALLOR Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.3 Adult Patients with Homozygous Familial Hypercholesterolemia EZALLOR Sprinkle is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.4 Limitations of Use EZALLOR Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias.

References: https://open.fda.gov/