Amarin announced that the FDA has accepted for filing its New Drug Application (NDA) for AMR101 for the treatment of patients with very high triglycerides (≥500mg/dL). The NDA for AMR101 is supported by data from both Phase 3 AMR101 clinical trials, MARINE and ANCHOR, in which AMR101 achieved all of the primary endpoints and was well tolerated, with a safety profile comparable to placebo.

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra-pure EPA (icosapent ethyl).

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