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DewDiligence

12/28/22 1:50 PM

#244872 RE: iwfal #244871

The FDA-AMRN lawsuit settlement involved promotion for off-label indications. What we’re discussing vis-à-vis RVNC is the more limited question of a drugmaker’s using published clinical data in its promotion.

This NEJM article from 2009 is on-topic:
https://www.nejm.org/doi/10.1056/NEJMhle0807695