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Amarin Corporation plc Message Board

  • mtdsus mtdsus Jun 19, 2013 10:26 AM Flag

    It is normal for FDA advisory panel for new drug for different indication.

    Almost all new drugs for new or different indication requires advisory panel.They look for 1) Safety 2) Benefits(significant or not) 3) Side effects--this is very important part of discussions.
    VIVUS,ARNA and many statin drugs including new ones by Regeneron,Sanofi etc.face similar scrutiny by a panel of exerts.FDA never approves a drug without such an input from a panel.Approval for TG 500mg./dl. had past experience on these issues,so no panel was needed for Vascepa.
    FDA has asked for larger studies to ensure small trials submitted bear out with larger group of people.Merck was asked to do the larger study,because of concerns with mixed drugs' larger study showed Niacin with new statin by Merck created side effects.
    FDA panels have to ask scientific questions in order to advise FDA for unusual problems for a drug for a different indication.
    Dr.Brinton opinion matters.

 
AMRN
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