Macrilen Approval Status
www.drugs.com/history/macrilen.html
Development Status and FDA Approval Process for Macrilen
Date§Article
Oct 26, 2016 Aeterna Zentaris Completes Patient Recruitment for Confirmatory Phase 3 Trial of Macrilen
Apr 13, 2015 Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of Macrilen in AGHD
Nov 6, 2014 FDA Issues Complete Response Letter for Macrilen (macimorelin) NDA in Adult Growth Hormone Deficiency
Jan 6, 2014 Aeterna Zentaris NDA for Macimorelin Acetate in AGHD Accepted for Filing by the FDA
Nov 5, 2013 Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD