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Re: CaptBeer post# 268347

Wednesday, 04/22/2020 2:13:30 PM

Wednesday, April 22, 2020 2:13:30 PM

Post# of 447424
https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs

I don't see anything in this FDA write-up that says that a generic drug has to address an unmet need. I do, however, see that there is a requirement that the container the drug is delivered in must be appropriate. I thought that Amarin has a patent for its encapsulation method. If so, is there a way that the FDA halts this due to the capsule being suggested or used by the generics?
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