Application Nr Approved Date Route Status External Links
BLA125390 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Myalept Is A Leptin Analog Indicated As An Adjunct To Diet As Replacement Therapy To Treat The Complications Of Leptin Deficiency In Patients With Congenital Or Acquired Generalized Lipodystrophy. ( 1 ) Limitations Of Use The Safety And Effectiveness Of Myalept For The Treatment Of Complications Of Partial Lipodystrophy Have Not Been Established. ( 1 ) The Safety And Effectiveness Of Myalept For The Treatment Of Liver Disease, Including Nonalcoholic Steatohepatitis (Nash), Have Not Been Established. ( 1 ) Myalept Is Not Indicated For Use In Patients With Hiv-Related Lipodystrophy. ( 1 ) Myalept Is Not Indicated For Use In Patients With Metabolic Disease, Without Concurrent Evidence Of Generalized Lipodystrophy. ( 1 ) 1.1 Patients With Generalized Lipodystrophy Myalept (Metreleptin) For Injection Is Indicated As An Adjunct To Diet As Replacement Therapy To Treat The Complications Of Leptin Deficiency In Patients With Congenital Or Acquired Generalized Lipodystrophy. Limitations Of Use The Safety And Effectiveness Of Myalept For The Treatment Of Complications Of Partial Lipodystrophy Have Not Been Established. The Safety And Effectiveness Of Myalept For The Treatment Of Liver Disease, Including Nonalcoholic Steatohepatitis (Nash), Have Not Been Established. Myalept Is Not Indicated For Use In Patients With Hiv-Related Lipodystrophy. Myalept Is Not Indicated For Use In Patients With Metabolic Disease, Including Diabetes Mellitus And Hypertriglyceridemia, Without Concurrent Evidence Of Congenital Or Acquired Generalized Lipodystrophy.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metreleptin

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