Icosapent Ethyl Capsules
Drug Details
- Generic Name
- Icosapent Ethyl Capsules
- Brand Names
- Icosapent Ethyl
- Application Number
- ANDA218994
- Sponsor
- Torrent Pharmaceuticals Limited
- NDC Codes
- 1
- Dosage Forms
- CAPSULE, LIQUID FILLED
- Routes
- ORAL
- Active Ingredients
- ICOSAPENT ETHYL
Indications and Usage
1 INDICATIONS AND USAGE Icosapent ethyl capsules are 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 capsules 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 capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. ( 1 )