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Amarin Corporation plc Message Board

  • dcsinvest dcsinvest Nov 14, 2012 7:17 PM Flag

    fDA have made their decision

    The FDA typically publishes a determination on the marketing exclusivity of recently approved products in a cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations , also known as the Orange Book, mid-month in the month following the drug’s approval. Vascepa was approved by the FDA in July 2012, but we have not yet been informed of a determination by the FDA on our pending exclusivity request for Vascepa. Since prior to FDA approval of the Vascepa new drug application, we have had an active dialogue with the FDA related to our marketing exclusivity request for Vascepa, which requested NCE status for Vascepa. In recent months, we have repeatedly followed up with the FDA seeking a determination. While we continue to believe our arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with our arguments. Based on our discussions with the FDA, we do not know what determination the FDA will reach regarding the pending exclusivity request for Vascepa or when the FDA will make such determination. We have been informed by FDA that the FDA has drafted a proposed response letter to our exclusivity request, that such draft response letter has been circulated internally at the FDA for comment and the FDA has been considering the issue actively. However, we have not been informed of the content of the FDA’s draft response and cannot, based on our communications with the FDA, make a reliable prediction as to when the FDA will communicate a determination on the matter. Accordingly, we have not been informed as to what determination the FDA will make with respect to pending Vascepa marketing exclusivity request. There can be no assurance that Vascepa will be granted NCE exclusivity, or that the FDA will make a determination on the pending exclusivity request in a timely manner.

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