Amarin Corp Plc (AMRN)

[sts66]

No big deal:




DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993
NDA 202057/S-009
SUPPLEMENT APPROVAL

Amarin Pharma, Inc.
Attention: Peggy Berry
VP, Regulatory Affairs and Clinical Quality
1430 Route 206, Suite 200
Bedminster, NJ 07921

Dear Ms. Berry:
Please refer to your Supplemental New Drug Application (sNDA) dated and received September 19, 2013, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Vascepa (icosapent ethyl) Capsules. We acknowledge receipt of your email dated November 12, 2013, stating your agreement to the labeling revisions that we communicated to you by email on November 4, 2013. This “Prior Approval” supplemental new drug application provides for the following revisions to
the package insert, in response to our letter dated July 15, 2013:

“8.3 Nursing Mothers
Studies withomega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion is unknown; caution should be exercised when Vascepa is administered to a nursing mother. An animal study in lactating rats given oral gave
C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.”