Helps diagnose adult growth hormone deficiency (AGHD). NDA 205598, held by Aeterna Zentaris. Macimorelin Acetate.
As of Nov 13, 2026, NDA 205598 (Macrilen), held by Aeterna Zentaris, was first approved by FDA on Dec 20, 2017, with 2 approved supplements and 0 published complete response letters.
MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
| Jul 23, 2026 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2017 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| MacrilenEQ 60MG BASE/POUCH · for solution;oral | Macimorelin Acetate | DiscontinuedReference drug |
| Jul 23, 2026 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Nov 27, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Dec 20, 2017 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
