Lowers the risk of total mortality. ANDA 211394, held by Pharmobedient. Simvastatin.
As of Nov 13, 2026, ANDA 211394 (Simvastatin), held by Pharmobedient, was first approved by FDA on Nov 27, 2024, with 0 approved supplements and 0 published complete response letters.
Simvastatin 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. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simvastatin10MG · tablet;oral | Simvastatin | Rx |
| Simvastatin20MG · tablet;oral | Simvastatin | Rx |
| Simvastatin40MG · tablet;oral | Simvastatin | Rx |
| Simvastatin80MG · tablet;oral | Simvastatin | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
