Amarin Corp Plc (AMRN)

[Biobillionair]

The last Citizen Petition was on 02/04/2014, Tommorrow marks the past due date. After this letter was posted on Yahoo, We may get an update within 4 days...the FDA may have informed Amarin today: Yep speculation...

http://www.calendarhome.com/calculate/days-from-a-date


Thank you for writing to Dr. John Jenkins, Director of the Office of New Drugs at the Food and Drug Administration (FDA), regarding Vascepa (icosapent ethyl). Please accept the following response from the Division of Drug Information on behalf of Dr. Jenkins.



We appreciate you sharing information about your current health condition. Vascepa was approved by FDA in 2012 for the reduction of triglyceride levels in adult patients with severe (=500 mg/dL) hypertriglyceridemia. Since it has received FDA marketing approval, Vascepa can be prescribed by a licensed physician based on the physician's professional opinion, if the physician believes the drug is appropriate for the patient. In general, physicians use their professional judgment to determine the best therapy for their patients based on the individual's medical history. This action is considered the practice of medicine.



Amarin submitted an application in February 2013, for Vascepa for concomitant use with a statin to reduce triglyceride (TG) levels in adults with TG levels of 200-499 mg/dL (referred to as the “ANCHOR” study or indication). Currently, Amarin’s application for Vascepa for the ANCHOR indication is pending, and FDA has not yet made a decision on this application. Furthermore, several citizen petitions have been submitted to FDA regarding the decision to rescind Amarin’s special protocol assessment agreement related to the ANCHOR indication.



Information on applications and citizen petitions pending before the Agency is confidential. Thus, with the exception of the information publicly disclosed at the October 16, 2013, Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting (transcript available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM376102.pdf), federal law generally prohibits FDA from discussing Amarin’s pending application and the pending citizen petitions. Because the application is unapproved, we recommend that you contact the sponsor if you would like information on the status of its application.



A copy of the citizen petition is available at FDA’s Division of Dockets Management at 5630 Fishers Lane, Room 1061, Rockville, MD, as well as electronically on Regulations.gov. The electronic docket is available at http://www.regulations.gov by typing “FDA-2013-P-1612” into the search box. While we cannot comment at this time on how the Agency will respond to the citizen petition, we appreciate your input on this topic. FDA encourages comments to be submitted to the docket within 180 days of submission of the citizen petition. The Agency will carefully consider all comments in responding to the citizen petition.



Thank you again for your message.



Best regards,



CCL

Division of Drug Information

Center for Drug Evaluation and Research
Food and Drug Administration


http://finance.yahoo.com/mb/AMRN/#mbt=Response%2520from%2520%25u2026&mbl=http%253A%2F%2Ffinance.yahoo.com%2Fmbview%2Fthreadview%2F%253B_ylt%253DAgfRyNoA0VU9UHKxzk6fLl3eAohG%253B_ylu%253DX3oDMTB2dWRlcHBhBHBvcwMyOARzZWMDTWVkaWFNc2dCb2FyZHNYSFJVbHQ-%253B_ylg%253DX3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-%253B_ylv%253D3%253F%2526bn%253D9ab0d884-3173-3957-a618-d4a469a0d4c3%2526tid%253D1407162512388-9c0ed65b-b534-4d28-8aca-09e79ab5e492%2526tls%253Dla%25252Cd%25252C3%25252C3&mbtc=mb-tab-topic