Macimorelin acetate
Macimorelin acetate is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Macrilen. Available dosage form: granule, for solution.
Drug Details
- Generic Name
- Macimorelin acetate
- Brand Names
- Macrilen
- Application Number
- NDA205598
- Sponsor
- Aeterna Zentaris GmbH
- NDC Codes
- 2
- Dosage Forms
- GRANULE, FOR SOLUTION
- Routes
- ORAL
- Active Ingredients
- MACIMORELIN
Indications and Usage
1 INDICATIONS AND USAGE MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency ( 1 ). Limitations of Use : The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m 2 ( 1 ). Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m 2 .