Aeterna Zentaris NDA filing for macimorelin acetate accepted by FDA Aeterna Zentaris announced that the Food and Drug Administration has accepted for filing the company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The company's NDA, submitted on November 5, 2013, seeks approval for the commercialization of macimorelin acetate as the first orally-administered product that induces growth hormone release to evaluate AGHD. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review, the company said.
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