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Re: rafunrafun post# 56801

Tuesday, 08/18/2015 11:12:57 AM

Tuesday, August 18, 2015 11:12:57 AM

Post# of 426248
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....

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