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Re: HinduKush post# 297378

Tuesday, 09/08/2020 4:56:45 PM

Tuesday, September 08, 2020 4:56:45 PM

Post# of 447455
I'll be damned - TGs > 500 is part of the R-IT label - I did not know that - it also removes the actual indication AMRN filed for in the sNDA, which was reduce CVE risk for patients with TGs 150-499. It never occurred to me that a new indication label would include prior indications too - at first glance it would seem this means generics are infringing on R-IT, but FDA labels and patents are different animals.

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