Amarin Corp Plc (AMRN)

[HDGabor]

raf-

It was discussed earlier on this board ... but here it is again:

FDA considers each ANDA “to have been submitted, but not yet received, notwithstanding our previous communications on this ANDA.” See “Clarification of Suspension of Review” FDA Letter Template Attachment and corresponding e-mail chain, Ex. A. FDA explained:

[B]ecause the Court has vacated FDA’s previous exclusivity determination for Vascepa, FDA currently has no exclusivity determination in effect for Vascepa. We generally cannot receive an ANDA until we have determined whether the reference listed drug is eligible for NCE exclusivity. See 21 C.F.R. 314.101(e)(2)(ii).

Best,
G