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Epanova Approval History

  • FDA approved: Yes (First approved May 5th, 2014)
  • Brand name: Epanova
  • Generic name: omega-3-carboxylic acids
  • Dosage form: Capsules
  • Company: AstraZeneca
  • Treatment for: Hypertriglyceridemia

Epanova (omega-3-carboxylic acids) is a fish oil-derived mixture of free fatty acids for the treatment of patients with severe hypertriglyceridemia.

Development History and FDA Approval Process for Epanova

May  6, 2014Approval FDA Approves Epanova for Severe Hypertriglyceridemia
Sep 18, 2013FDA Accepts New Drug Application for Investigational Compound Epanova for the Treatment of Severe Hypertriglyceridemia
Jul  9, 2013Omthera Pharmaceuticals Announces NDA Submission for Epanova for the Treatment of Patients with Very High Triglycerides

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