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
|Dec 20, 2017|| Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency|
|Jul 18, 2017||NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date|
|Jun 30, 2017||Aeterna Zentaris Resubmits NDA for Macrilen for the Evaluation of Growth Hormone Deficiency in Adults|
|Mar 30, 2017||Aeterna Zentaris Intends to File NDA with Respect to Macrilen in Third Quarter of 2017|
|Feb 13, 2017||Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen|
|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|
|Oct 6, 2010||Aeterna 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, 2010||Aeterna 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|
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