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Amarin (AMRN) Says FDA Panel Meeting Will Not Be Scheduled Related to NDA for AMR101

February 13, 2012 8:10 AM EST
AMRN Hot Sheet
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EPS Growth %: -200.0%
Amarin Corporation plc (Nasdaq: AMRN) announced today that it was informed by the U.S. FDA that no advisory committee meeting will be scheduled in connection with the FDA's review of the 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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