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Macrilen Approval Status

Macrilen (macimorelin) is a ghrelin agonist in development for use in evaluating adult growth hormone deficiency (AGHD).

Development Status and FDA Approval Process for Macrilen

DateArticle
Jun 30, 2017Aeterna Zentaris Resubmits NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults
Mar 30, 2017Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017
Feb 13, 2017Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen
Oct 26, 2016Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen
Apr 13, 2015Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD
Nov  6, 2014FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency
Jan  6, 2014Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA
Nov  5, 2013Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD

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