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Re: rosemountbomber post# 386109

Friday, 08/12/2022 2:28:50 PM

Friday, August 12, 2022 2:28:50 PM

Post# of 428972
RMB, The label is identical as it pertains to the MARINE indication. That is the indication they are approved for. The R-IT approval information is not on the label. FDA considers gv to be an AB rated generic for Vascepa in that indication. The problem is that Vascepa is the same drug for either indication. That is why it is medically legal to substitute the generic for the R-IT indication. Lovaza could not be substituted. Different drug. A self emulsifying version would be a different drug with different dosing instructions.
Sleven,
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