Hanmi First Korean Firm To Follow U.S. FDA 505(b)(2) Pathway; AstraZeneca Files Suit For Nexium
This article was originally published in PharmAsia News
Executive Summary
SEOUL - Hoping to become the first Korean pharmaceutical company to sell modified generics in the U.S., Korea's Hanmi Pharmaceutical filed for U.S. FDA approval for the sale of Esomezol, its modified generic of AstraZeneca's Nexium (esomeprazole), but must first overcome a patent infringement lawsuit