Dukes., additionally, one could easily research the innumerous manufacturing violations these two Generics have been slapped with. Many are fairly recent. Can you imagine these two Generics applying the same meticulous manufacturing standards Amarin applies?
They can't produce 20-year off-patent basics long enough before the next violation is discovered. Good luck to them.
You couldn't find evidence of FDA requiring a plant inspection prior to ANDA approval because there isn't any - postes just thinks it is - you should know better than to take him at his word. Some people also have claimed you need to prove you can make X amount of a generic drug for ANDA approval - that's also false. The FDA is totally over burdened with foreign plant inspections for companies that are already making drugs, let alone facilities for a new generic - so short handed sometimes there's many years in between inspections.
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