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Aurobindo Receives FDA Approval for Icosapent Ethyl Capsules, 1 gram

Published: June 24, 2026

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Icosapent Ethyl Capsules, 1 gram. Aurobindo Pharma’s Icosapent Ethyl Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Vascepa Capsules, manufactured by Amarin Pharmaceuticals Ireland, Limited.

Icosapent Ethyl Capsules are indicated as an:

  • Adjunct to diet to reduce Triglycerides (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.