Details of the Drug Formulations

General Information of Drug (ID: DME6G97)

• Drug Name: Lefamulin Drug Info
• Synonyms: UNII-21904A5386; 1061337-51-6; CHEMBL3291398; 21904A5386; Lefamulin [INN]; Acetic acid, 2-(((1R,2R,4R)-4-amino-2-hydroxycyclohexyl)thio)-, (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyldecahydro-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-3a,9-propano-3ah-cyclopentacycloocten-8-yl ester; Lefamulin(BC-3781); Lefamulin [USAN:INN]; Acetic acid, 2-[[(1R,2R,4R)-4-amino-2-hydroxycyclohexyl]thio]-, (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyldecahydro-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-3a,9-propano-3aH-cyclopentacycloocten

Indication

Disease Entry	ICD 11	Status	REF
Community-acquired pneumonia	CA40.Z	Approved	[1]
Acute bacterial skin infection	1C41	Phase 2	[2]

• Cross-matching ID:
  PubChem CID: 25185057
  CAS Number: 1061337-51-6
  TTD ID: D0EB5N
  INTEDE ID: DR0919
  ACDINA ID: D01201

Full List of Drug Formulations Containing This Drug

Lefamulin 600 mg tablet

Company	Formulation ID	FDA Description
Nabriva Therapeutics Us	F23802	Colloidal Silicon Dioxide; Croscarmellose Sodium; Fd&C Blue No 2 Aluminum Lake; Ferrosoferric Oxide; Magnesium Stearate; Mannitol; Microcrystalline Cellulose; Polyethylene Glycol; Polyvinyl Alcohol (Partially Hydrolyzed); Povidone K30; Shellac Glaze; Talc; Titanium Dioxide

Lefamulin 150 mg Injection

Company	Formulation ID	FDA Description
Nabriva Therapeutics Us	F23803	Sodium Chloride; Water For Injection; Citric Acid Anhydrous; Sodium Chloride; Trisodium Citrate Dihydrate; Water For Injection

References

• [1] Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health Human Services. 2019
• [2] Clinical pipeline report, company report or official report of the Pharmaceutical Research and Manufacturers of America (PhRMA)