Amarin Corp Plc (AMRN)

[amarininvestor]

My understanding is that the FDA asked TEVA to change the label. In our case that would be equivalent of having the FDA to ask generics to change the label to cover cardiovascular disease. Unless that occurs, I don't think this ruling applies to us (see text below from today's ruling)



In 2011 the FDA required Teva to amend its carvedilol
label to be “identical in content to the approved [GSK
Coreg®] labeling (including the package insert and any
patient package insert and/or Medication Guide that may
be required).” Dist. Ct. Op. at 587. Teva amended its label
to include the indication for treatment of heart failure, as
required by the FDA. Dist. Ct. Op. at 587.