Eton Pharmaceuticals (ETON) said Friday a bioequivalence study of its product candidate ET-600 showed pharmacokinetic equivalence to the U.S. Food and Drug Administration (FDA)-approved reference product of the same active ingredient.
ET-600 is an oral solution of desmopressin under development for the treatment of central diabetes insipidus.
Eton said it expects to submit a new drug application to the agency for ET-600 in April, based on the trial results.
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