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Re: BiotechWill post# 11257

Thursday, 07/25/2013 7:55:11 PM

Thursday, July 25, 2013 7:55:11 PM

Post# of 426493
BiotechWill :

Does it mean for drugs that receive NCE designation from the FDA on PDUFA should be listed as NME by CDER? In the case of Vascepa, since FDA was unable to determine its NCE status on PDUFA, CDER listed Vascepa NME status as "no" for the time being, right? TIA.
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