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Re: HDGabor post# 31365

Wednesday, 07/30/2014 12:47:06 PM

Wednesday, July 30, 2014 12:47:06 PM

Post# of 430218
It is my understanding that the new policy is inapplicable here as it is new. Furthermore Lovaza's active ingredient was an indistinguishable mixture and Amarin's contention is that since the NCE granted at that time was for the mixture and no single ingredient that the FDA cannot come back now and parse out an ingredient of that mixture and say it was already approved.
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