Amarin Corp Plc (AMRN)

[Biobillionair]

Vascepa's label is being updated By December 9th.

11-25-2013 FDA letter:

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.

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[9-19 What is this communication? This is the supplement approved, Is it Amarin's proposed Anchor Label before Ad Com?]
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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.

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[I believe this was the request to change 8.3, as this was agreed on and done before this letter was dated]
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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:

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[FDA's pretending Oct 16th never happened?]
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“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 gavage 14C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma.”

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[The above is not the only change, the changes still to be made to the label refer to the 9-19-2013 sNDA, I don't know but this may be the agreed label negotiated before the Oct 16 Ad Com. It could also be why the FDA was so aggressive at the Ad Com]
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APPROVAL & LABELING
We have completed our review of this supplemental application. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.

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[8.3 label was already done before this letter but after the 11-12, this supplemental approval refers to the sNDA from 9-19-2013]
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Content of Labeling:
-structured product labeling (SLP) & (CBE)
-Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application, as well as annual reportable changes and annotate each change. To facilitate review of your submission, provide a highlighted or marked- up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy should provide appropriate annotations, including supplement number(s) and annual report date(s).

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[more changes within 14 days of this letter dated 11-25]
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PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with annotated references, and (3) the package insert(s) to:
Food and Drug Administration
Center for Drug Evaluation and Research Office of Prescription Drug Promotion (OPDP) 5901-B Ammendale Road
Beltsville, MD 20705-1266
You must submit final promotional materials and package insert(s), accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions are provided on page 2 of the form. For more information about submission of promotional materials to the Office of Prescription Drug Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for

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[content labeling and promotional labeling! doesn't make sense for just 8.3 change]
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I know this is hard to follow and harder to believe, but I think we get whatever we asked for on 9-19-2013....and only Amarin and the FDA know what the heck that is?
sNDA 5,6,7,or 8 comes after 9 and includes new labeling, let's hope if full label negotiated 9-19-2013 before this horrible Ad Com disaster.

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

Peace out----my last post!