Amarin Corporation PLC (AMRN) Announces FDA Advisory Committee Will Not Be Scheduled in Connection With New Drug Application for AMR101
2/13/2012 10:13:07 AM
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 13, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company with a focus on cardiovascular disease, announced today that it was informed by the U.S. Food and Drug Administration (FDA) that no advisory committee meeting will be scheduled in connection with the FDA's review of the New Drug Application (NDA) seeking approval for the use AMR101 in the treatment of patients with very high triglycerides (=500mg/dL), the company's lead product candidate. The FDA has previously assigned a Prescription Drug User Fee Act (PDUFA) date of July 26, 2012 for completion of its review of the AMR101 NDA.
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