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AMARIN PHARMA. IRELAND v. FOOD AND DRUG ADMIN.

Civil Action No. 14-cv-00324 (RDM).

106 F.Supp.3d 196 (2015)

AMARIN PHARMACEUTICALS IRELAND LIMITED, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services, Defendants.

United States District Court, District of Columbia.

Signed May 28, 2015.

Attorney(s) appearing for the Case

Christopher N. Sipes , Benjamin C. Block , Bradley K. Ervin , Covington & Burling LLP, Matthew Joseph Berns , U.S. Department of Justice, Washington, DC, for Plaintiff.

Ann Frances Entwistle , Gerald Cooper Kell , Andrew E. Clark , Cindy Jane Cho , U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

Amarin Pharmaceuticals Ireland Limited ("Amarin") challenges the Food and Drug Administration's determination that Amarin's new drug, Vascepa (icosapent ethyl) Capsules ("Vascepa"), is not entitled to a five-year...

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