Replies to post #262437 on Amarin Corp Plc (AMRN)

[HDGabor]

D-

Meanwhile it was not a direct reply I posted my view about the label "issue". Shortly:

ANDAs must include the proposed labelling that will accompany the generic drug—and that labelling must generally be substantially the same as the labelling that accompanies the brand-name drug.

It should be read … applicable as "per indication" not as a label entirely. (ergo: R-IT should not be included in ANDAs' label).

Best,
G