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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

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PharmAsia News Business Bulletin

A regular roundup of commercial stories appearing in Scrip’s sister publication PharmAsia News, whose multilingual team of regional experts provides authoritative business intelligence focused on the Asian marketplace. Full stories can be accessed by clicking on the story title (subscription required).

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