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Alias Born 01/12/2013

Re: None

Friday, 08/16/2013 10:09:48 AM

Friday, August 16, 2013 10:09:48 AM

Post# of 429367
What indication did Amarin ask for?

This document claims we will be discussing Anchor, combination use ie. AMR 102, and treatment of CV disease. Anchor 200-500 is not specifically mentioned.


Docket # FDA 2013 N 0001

General Function of the meeting:
To provide advice and recommendations to the Agency on FDA's regulatory issues.

Agenda: To discuss the supplemental new drug application 202057/S-005

This supplemental ap proposes concomitant use with an inhibitor of HMG-CoA to reduce trigs, non HDL, APO B, LDL, very low LDL in mixed dys, CHD, or
CHD risk equivalent.
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What exactly is the FDA up to here?


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