Re the Orange Book: It seems a company can include patents in its NDA submission which by and large the FDA will include in the Orange Book if the NDA is approved. If the company obtains further patents after approval will the FDA also list these or is the patent listing limited to time of submission?..
This meeting is a little strange so close to the PDUFA date. In searching thru the FDA's site, I couldn't find another example of such a meeting(which date back to 2007).
I suspect the FDA issued something to AMRN earlier and they requested a meeting to clarify. It certainly has a hint of bearishness to it.
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