AMR 101 (Amarin Corpn)is filed at the FDA for High Triglycerides

A New Drug Application for AMR101 (ethyl EPA) from Amarin Corporation has been accepted for filing by the FDA. Amarin seeks approval to market and sell AMR 101 in the United States for the indication studied in the MARINE trial�the treatment of patients with very high triglycerides (=500mg/dL). The NDA for AMR 101 is supported by data from both Phase III clinical trials, MARINE and ANCHOR, in which trials AMR 101 achieved all of the primary endpoints and was well tolerated with a safety profile comparable to placebo. The application will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012.