Hanmi receives tentative FDA approval for incrementally modified Nexium capsules

Hanmi Pharmaceutical said Sunday that the U.S. Food and Drug Administration has recently granted tentative approval to the company's New Drug Application (NDA) for esomeprazole strontium delayed-release capsules.

Hanmi’s NDA was filed with the U.S. FDA including comparative bioequivalence testing against AstraZeneca's Nexium (esomeprazole magnesium delayed-release capsules).

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