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Arena Pharmaceuticals, Inc. Message Board

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  • hakujinchad hakujinchad Jun 12, 2012 11:28 PM Flag

    Official FDA Approval/Disapproval Site Link

    thank you so much reacre! I didn't see it, maybe put in bad search terms.

    quick question since I have your attention. I know that 'approval' is the best outcome, but how to interpret labeling revision? see a lot on the first page w/ that. Anything to do w/ rems or a delay?

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    • "how to interpret labeling revision"

      jeez. This is called Due diligence. Some of us have been doing it on ARNA for years now.

      Label revisions have NOTHING to do with REMS for drugs n pre-approval stage. FDA regulates everything regarding how a drug is marketed including the exact wording on the drug's label, package insert etc. FDA has to approve all changes to the label.

      Label revisions can often be due to expansion of the label to other therapeutic areas, but they can also be new restrictions based on emerging clinical signals.

      Once Lorcaserin is approved. You will find Eisai and ARNA do a short clinical trial in diabetics with a primary endpoint of Hba1C reduction and sometime in mid-2014 you'll see Lorcaserin on that list as "label revision" when they expand the label to approve Lorcaserin 10mg QD as an anti-daibetic agent.

    • also, do they post in real time, or is it normally at the end of the day or something? I keep ARNA press release page bookmarked, but you know how they can be kinda slow sometimes (all companies, particularly when posting earnings statements, after the news is 'out'.)

 
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