Last Updated: Tuesday, 23-Apr-2013 16:00:00 EDT
Amarin Announces FDA Acceptance of Supplemental Drug Application for Vascepa
On April 23, Amarin Corp. issued a press release announcing that the U.S. FDA has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia.
The FDA's review of Vascepa is expected to be completed by December 20, 2013.