Amneal Pharmaceuticals, L.L.C. announced that it has entered into a license and distribution agreement with Hanmi Pharm. 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(R) (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.