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Number sleven

07/02/25 3:19 PM

#437140 RE: JRoon71 #437139

JRoon, First. FDA is the organization that ultimately decides what is and is not on the label. Every generic company has a discussion with FDA, but FDA position remains constant. If you want to read any of the generic labels they are easy to find with Google. Second. No. We needed an overt act of inducement in order to get past the pleading stage. Hikma was cooperative. If the court decides that the label is a "partial label" it would immediately apply to the other generic companies.
Sleven,
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Tatsumaki

07/02/25 6:14 PM

#437149 RE: JRoon71 #437139

The most likely Amarin positive outcome of this trial is that Hikma gets told they should have disclaimed the use of the product for non labeled indications on the label itself. Perhaps some damages paid. Industry wide result, all future skinny label drugs, including the other EPA geneircs, will just include disclaimers on the label. Everyone down stream of the generic manufacturer; Dr's... insurers... patients... will continue to use it however they want for any end use. As codified by HW, skinny labels are 100% legal and by design, encouraged to force competition on branded drugs for the benefit of the US population. There will be no elimination of generic EPA across the board.

It's like a guy with a patent on ice yelling at everyone with a freezer in their house that they cant make ice.
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Number sleven

07/04/25 11:54 AM

#437175 RE: JRoon71 #437139

JRoon, If you want to understand how the lawyers can use this case to invalidate every generic label, read the link in my last post.
Sleven,