BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, LLC today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., Ltd to acquire exclusive distribution rights to Hanmi’s new drug application (NDA), currently under FDA review, for esomeprazole strontium delayed-release capsules. Hanmi’s NDA was filed with the U.S. FDA pursuant to Section 505(b)(2) of the Food, Drug and Cosmetic Act including comparative bioequivalence testing against AstraZeneca’s Nexium® (esomeprazole magnesium delayed-release capsules). Originally submitted to the FDA in October 2010 with additional development data subsequently provided by Hanmi, the NDA has been granted a revised Prescription Drug User Fee Act (PDUFA) date of April 29, 2013.
