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Macrilen Approval History

FDA Approved: Yes (First approved December 20, 2017)
Brand name: Macrilen
Generic name: macimorelin
Dosage form: for Oral Solution
Company: Aeterna Zentaris, Inc.
Treatment for: Diagnosis of Adult Growth Hormone Deficiency

Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

Development History and FDA Approval Process for Macrilen

DateArticle
Dec 20, 2017Approval Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
Jul 18, 2017NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date
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
Oct  6, 2010Aeterna Zentaris Announces Orphan Drug AEZS-130 (Macimorelin, Solorel) Interim Phase 3 Data Analysis Shows Potential for 2011 Filing as Oral Diagnostic Test for Adult Growth Hormone Deficiency (AGHD)
Sep 28, 2010Aeterna Zentaris: Poster on Diagnostic Use of Oral Synthetic Growth Hormone Secretagogue/Ghrelin Receptor Agonist, AEZS-130 (Macimorelin, Solorel) to be Presented at Upcoming 5th International Congress of the GRS-IGF Society in New York

Further information

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