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Re: None

Monday, 04/15/2013 3:06:31 PM

Monday, April 15, 2013 3:06:31 PM

Post# of 424469
4-23-2013 is the issue date for 13608744.

It happens to claim a pharmaceudical ingrediate containing >95% EPA with no DHA and claim #8 is the reduction of apolipoprotein B.

APO B are the primary apolipoproteins of chylomicrons and LDL. The significance being Lovaza raises LDL's while Vascepa does not.

It also is currently a difference in the two approved labels. Vascepa lowers APO B by 4% while stats for Lovaza are only included with the combination of Lovaza and Simvastatin.

Without the OB of a Anchor patent this patent separates Lovaza and Vascepa, enough for NCE decision...who knows?4-12-2013 "Manufacturing Change or Addition" on FDA site.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
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