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Subsequent Events | 3 Months Ended
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Mar. 31, 2015
Subsequent Events |
(11) | Subsequent Events
The Company has evaluated subsequent events from March 31, 2015 through the date of the issuance of these condensed consolidated financial statements. On April 27, 2015, the Company received a Complete Response Letter (“CRL”) from the FDA regarding its ANCHOR trial supplemental New Drug Application (the “ANCHOR sNDA”). The ANCHOR sNDA sought to expand approved Vascepa labeling to include use as an adjunct to diet to reduce triglyceride levels in adult patients on statin therapy with mixed dyslipidemia (one or more lipid disorder) and triglyceride levels from 200 to 499 mg/dL. Vascepa remains FDA approved for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and current Vascepa labeling remains unchanged. On May 7, 2015, Amarin Pharma, Inc., a wholly-owned subsidiary of the Company, and a group of independent physicians filed a federal lawsuit to permit the Company to share truthful and non-misleading information, including the ANCHOR trial clinical data, with healthcare professionals in the United States about uses of Vascepa that are consistent with multiple national and international treatment guidelines and relevant to patients in the United States at risk of cardiovascular disease. The lawsuit, captioned, Amarin Pharma, Inc. et al. v. Food & Drug Administration, et al., was filed in the United States District Court for the Southern District of New York and seeks a judicial declaration based on several legal theories.

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- Definition The entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business. + References No definition available. + Details
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