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Biobillionair

04/16/13 2:28 PM

#4308 RE: kaylawa #4305

No Kay, that was the first change, 001. The second was adding Catalent Parma to Banner as the two capsulators (last page of label 000 compared to 002). Those are the only two encapsulation companies Amarin has contracted.

We don't know what the "04/12/2013 003 Manufacturing Change or Addition" letter, label or review is blank for now. It took several days for 002 new label to be posted.

It's most likely an acceptance of one of Amarin's API suppliers.


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