Source: FDA, National Drug Code (US) Revision Year: 2019
MACRILEN for oral solution is macimorelin acetate, a synthetic growth hormone secretagogue receptor agonist. Macimorelin acetate is described chemically as D-Tryptophanamide, 2-methylalanyl-N-[(1R)1(formylamino)- 2-(1H-indol-3-yl)ethyl]-acetate.
The molecular formula for macimorelin acetate is C28H34N6O5 with a molecular weight of 534.6 g/mol.
Figure 1. Chemical structure of macimorelin acetate:
Each aluminum pouch of MACRILEN contains 60 mg of macimorelin, equivalent to 68 mg of macimorelin acetate, and the following inactive ingredients: lactose monohydrate, crospovidone, sodium stearyl fumarate, saccharin sodium and colloidal silicon dioxide.
| Dosage Forms and Strengths |
|---|
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For oral solution: 60 mg white to off-white granules in a pouch for reconstitution in 120 mL of water, resulting in a solution of 0.5 mg/mL of macimorelin. |
| How Supplied |
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MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water provides a 60 mg/120 mL (0.5 mg/mL) macimorelin solution. MACRILEN is available in boxes containing 1 pouch per box (NDC 0169-1401-01). Before administration, MACRILEN for oral solution must be reconstituted by a healthcare professional [see Dosage and Administration (2.3)]. Manufactured by: Allphamed Pharbil Arzneimittel GmbH, Goettingen, Germany Distributed by: Novo Nordisk Inc. Plainsboro, NJ, USA |
| Drug | Countries | |
|---|---|---|
| MACRILEN | United States |
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