Amarin's Asking ITC To Do FDA's Job, Federal Attorneys Tell Supreme Court
In petition to Supreme Court, Amarin does not assert it makes any fair trade claim "that could be proved without establishing" an FDCA violation, nor does it dispute that its "claims are ultimately premised on allegations that the FDCA was violated," say DoJ solicitor general and ITC counsel.
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The court included its decision on Amarin’s ’s petition for a writ of certiorari among the single-line denials of nearly 200 appeals to consider decisions in civil litigation and convictions in criminal cases. However, Amarin still eyes curbing competition from omega-3 supplements.
Sales of the triglyceride-lowering medicine soared to $112.4m in the third quarter even before a label expansion that depends on the outcome of a vital US FDA advisory committee meeting on 14 November.
As Amarin expects jump in Vascepa sales from potential label expansion allowing larger patient group, John Thero notes competitors fail to show broader cardiovascular risk reduction, but consumers still hear omega-3 supplements "might work."