Amarin (AMRN) Discloses Delay in Vascepa NCE Status
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Amarin Corporation plc (Nasdaq: AMRN) announced an delay on the FDA decision to grant Vascepa NCE status.
From 8-k:
On August 17, 2012, the U.S. Food and Drug Administration (FDA) is expected to publish the July 2012 cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book (the July Orange Book Supplement), in which, among other things, FDA will list new product approvals, issued patents related to such products and associated regulatory exclusivity grants made pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Vascepa™ (icosapent ethyl) Capsules is expected to be included in the July Orange Book Supplement along with U.S. Patent No. 8,188,146 (a pharmaceutical composition patent known as the EPA with no DHA in a capsule patent). No entry is expected to be made with respect to the regulatory exclusivity status of Vascepa in the July Orange Book Supplement. Based on information available to Amarin Corporation plc (Amarin) as of the filing of this report on August 17, 2012, including communication with FDA on August 16, 2012, FDA has not yet made a determination with respect to regulatory exclusivity for Vascepa.
From 8-k:
On August 17, 2012, the U.S. Food and Drug Administration (FDA) is expected to publish the July 2012 cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book (the July Orange Book Supplement), in which, among other things, FDA will list new product approvals, issued patents related to such products and associated regulatory exclusivity grants made pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Vascepa™ (icosapent ethyl) Capsules is expected to be included in the July Orange Book Supplement along with U.S. Patent No. 8,188,146 (a pharmaceutical composition patent known as the EPA with no DHA in a capsule patent). No entry is expected to be made with respect to the regulatory exclusivity status of Vascepa in the July Orange Book Supplement. Based on information available to Amarin Corporation plc (Amarin) as of the filing of this report on August 17, 2012, including communication with FDA on August 16, 2012, FDA has not yet made a determination with respect to regulatory exclusivity for Vascepa.
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