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Re: KCSVEN post# 199378

Tuesday, 07/02/2019 7:59:07 AM

Tuesday, July 02, 2019 7:59:07 AM

Post# of 426304
KCS...In 2016 the FDA and Amarin settled their first amendment case...part of the settlement stipulated that...

"federal court ruling that said Amarin had a free speech right to tell doctors about studies supporting the use of the fish-oil derived cardio drug Vascepa for uses not approved by the FDA as long as they are truthful. It sets up an "optional" procedure for Amarin to submit marketing materials to the FDA for approval twice a year if it wants to get preclearance of marketing material."

In my memory, this optional procedure has not been used by Amarin...Could this agreement be used to facilitate earlier DTC adds?
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