Replies to post #56801 on 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

[Williams4076]

Hey Raf,
Good point, but IMO FDA is again unclear with true message by using a double negative. Epanova was awarded 3 yrs NME at date of approval. Same time Vascepa was changed from 3 yrs NME so was Epanova..both had prior dates of expiration of NME...both changed to "There is no unexpired exclusivity for this product".

http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=205060&Product_No=001&table1=OB_Rx

The use the same term to mean different things...LOL just like Active Ingredient and Moiety....

BB