Daptomycin is a lipopeptide antibacterial agent active against gram-positive bacteria.
Indication: Used in the treatment of complicated skin and skin structure/soft-tissue infections caused by susceptible isolates of gram-positive bacteria such as Staphylococcus aureus (including MRSA-methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae supsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible isolates only).
Additionally used for bloodstream infections (bacteremia), including patients with right-sided infective endocarditis caused by Staphylococcus aureus.
Application: Administered as intravenous infusions or injections.
Dosage form |
Lyophilized vials |
|||||
Strength |
350 mg 500 mg |
|||||
Compliance |
No monograph for daptomycin in either Ph. Eur. or USP available |
|||||
Manufacturing site |
CMO for Xellia Pharmaceuticals ApS Xellia Pharmaceuticals ApS, Copenhagen, Denmark (for US only) |
|||||
Release site |
CMO for Xellia Pharmaceuticals ApS Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
|||||
Site registered |
EU GMP issued by Danish Medicines Agency US FDA Other health authorities |
|||||
Batch size |
|
|||||
Regulatory documentation |
EU dossier US dossiers RoW* dossier |
|||||
Packaging sizes |
|
|||||
Shelf life |
| |||||
Storage conditions |
| |||||
* Rest of the World
