Amarin Corporation PLC Still Awaits FDA OK for Heart Drug
Published: Sep 11, 2012
Amarin Corp said the U.S. health regulator is yet to decide on granting exclusive marketing rights to its heart drug Vascepa, sending its shares down 3 percent In extended trading. Based on its talks with the U.S. Food and Drug Administration, Amarin does not expect the FDA's Orange Book Supplement to include an entry with respect to the regulatory exclusivity status of Vascepa. the company said. The FDA publishes an Orange Book, which includes details of recently approved products, patent and exclusivity information.