The FDA approves the label proposed by the applicant. Amarin does not need to include Marine label.on a new formula/dose change if they dont want to when they file.
Take Mounjaro and Zepbound as an example. Exact same API. Exact same drug formulations (excipients). Exact same delivery system. Same packaging. Same shelf life. Different dosing requirements. Different indications. Different name. FDA didnt mandate cross referencing other indications due to similarities. Ozempic and Wegovy same deal
Was done so insurers could differentiate coverage levels based on end use. Same argument applies to the emulsified product if its ever launched.
Thanks sleven. I was just responding to Hayden's comment on us (Amarin) just dropping the current patent and move forward with the new one. I don't think we can just ask the FDA to drop the current patent and come out with the new LR patent.
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