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BioInvestor3

08/13/22 2:19 PM

#386187 RE: ziploc_1 #386179

Zip,
There are reasons why FDC is done, I can think of many examples of this but very few examples of combination products.
Regardless it's a mute point because Amarin is doing FDC, no point in talking about something they won't do.

The answer to why the FDC is done lies here:

https://www.fda.gov/files/drugs/published/New-Chemical-Entity-Exclusivity-Determinations-for-Certain-Fixed-Combination-Drug-Products.pdf

https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity