News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Amarin Corporation PLC (AMRN) Announces FDA Award Of Three-Year Exclusivity For Vascepa® (Icosapent Ethyl) Capsules


2/24/2014 9:01:39 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 21, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) has awarded three years of marketing exclusivity to Vascepa® (icosapent ethyl) capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice to Amarin of the acceptance of an application to the FDA seeking approval of a generic version of Vascepa. FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.

Help employers find you! Check out all the jobs and post your resume.

Read at GlobeNewswire


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES