WIll not the FDA have to change some rules regarding NCE for AMRN to be considered
I am not as much up with AMRN since i sold out a while back. So I am asking this board if the FDA has been considereing some rule changes regarding giving NCE status to drugs. And that it would follow that no NCE decision will be made, either yes or no, until those potential rule change have been adressed. I have been looking for that to determine if I am to get back in with AMRN. IOW, no rule change,then no decision by the FDA.
ICOSAPENT ETHYL CAPSULE; ORAL 1GM VASCEPA AMARIN PHARMA INC
FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Generic Drug Product Information & Patent Information - Patent and Generic Drug Product Data Last Updated: February 14, 2013
It shows it being on the market and that patent information was updated yesterday... I do not see any update regarding the Orange Book status for today. Am I reading it wrong? Went to the Orange Book site and it did not appear to be updated yet today.