icosapent ethyl
Drug Details
- Generic Name
- icosapent ethyl
- Brand Names
- icosapent ethyl, Vascepa, ICOSAPENT ETHYL
- Application Number
- ANDA217656
- Sponsor
- Patheon Softgels B.V.
- NDC Codes
- 22
- Dosage Forms
- CAPSULE, CAPSULE, LIQUID FILLED
- Routes
- ORAL
- Active Ingredients
- ICOSAPENT ETHYL
Indications and Usage
1 INDICATIONS AND USAGE Icosapent ethyl is indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) indicated: • as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. ( 1 ) Limitations of Use: • The effect of icosapent ethyl on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )