Hikma gets FDA green light for generic Vascepa
The Food and Drug Administration has approved Hikma’s generic of Amarin's Vascepa (icosapent ethyl capsules). The drug has been approved in 1-gram dosage strength.
In March, the United States District Court for the District of Nevada invalidated six key Vascepa patents owned by Amarin. The District Court decision is currently being appealed.
“The approval for our generic version of Vascepa is an important milestone towards bringing this product to market," said Brian Hoffmann, Hikma president of generics. "This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the United States with the high-quality medicines they need."