Two medicines, side by side
Pitavastatin vs simvastatin
Pitavastatin and simvastatin are both labeled for high cholesterol. Drugs@FDA records approvals of pitavastatin since 2009 and of simvastatin since 1991. Pharmacies paid $0.954 per pitavastatin 2 mg tablet and $0.0321 per simvastatin 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Pitavastatin, “Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic …”; Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”
Check it at the source: the pitavastatin FDA label on DailyMed (effective March 31, 2026); the simvastatin FDA label on DailyMed (effective March 28, 2025).
Highlights of the pitavastatin record
Pitavastatin (Livalo) · label of March 31, 2026
Used for
From the label: indicationsLIVALO is 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). […]
On the market
- Earliest approval on file
- August 3, 2009
- Generic labelers
- 12 labelers
- Pharmacy cost
- $0.954 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 7
Highlights of the simvastatin record
Simvastatin (Zocor) · label of March 28, 2025
Used for
From the label: indicationsZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. […]
On the market
- Earliest approval on file
- December 23, 1991
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.0321 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 26
Source: FDA drug labels via openFDA (Pitavastatin label of March 31, 2026, Simvastatin label of March 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do pitavastatin and simvastatin differ on the record?
How each works, in its label's words: Pitavastatin, “Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic …”; Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”
Both are in FDA's class HMG-CoA reductase inhibitors.
Generics: pitavastatin since 2016; simvastatin since 2006 (Drugs@FDA).
| Pitavastatin | Simvastatin | |
|---|---|---|
| Labeled for | High cholesterol | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Pharmacologic class | HMG-CoA Reductase Inhibitor | HMG-CoA Reductase Inhibitor |
| How it works (label) | Pitavastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a rate-limiting step in the biosynthetic pathway for cholesterol. | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. |
| Half-life (label) | The mean plasma elimination half-life is approximately 12 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | August 3, 2009 | December 23, 1991 |
| First generic approved | December 20, 2016 | June 23, 2006 |
| Generic labelers (NDC) | 12 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.954 per tablet (Pitavastatin 2 mg tablet) | $0.0321 per tablet (Simvastatin 20 mg tablet) |
| 12-month price change | -34% | +5% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 7 | 26 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 10,225 | 248,728 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to pitavastatin
- every medicine labeled for the same conditions