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Atom0aks

11/20/19 7:52 PM

#229009 RE: marzan #229008

FDA wouldn't approve with no proof on manufacturing or supply in enough quantity by the producer.



I don't think that's a requirement by the FDA for labelled drugs. As far as I'm aware, Vascepa is available in inventories of most wholesalers.

Edit: Here is a quote from their last 10-K,

We sell Vascepa principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, our Distributors or our customers, that in turn resell Vascepa to retail pharmacies for subsequent resale to patients and healthcare providers.



Source: https://investor.amarincorp.com/static-files/093f514b-85fe-46ae-b3f9-a0da32d59be7