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| AMRN > SEC Filings for AMRN > Form 8-K on 17-Aug-2012 | All Recent SEC Filings |
17-Aug-2012
Regulation FD Disclosure
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.
This Current Report on Form 8-K contains forward-looking statements, including statements concerning FDA's consideration of regulatory exclusivity with respect to Vascepa, the timing of any such determination and expected publication of the July Orange Book Supplement. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A list and description of risks, uncertainties and other matters related to an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this Current Report on Form 8-K, whether as a result of new information, future events or circumstances or otherwise.
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