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 |
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Strength |
350 mg 500 mg |
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Compliance |
No monograph for daptomycin in either Ph. Eur. or USP available |
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Manufacturing site |
CMO for Xellia Pharmaceuticals ApS |
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Release site |
CMO for Xellia Pharmaceuticals ApS Xellia Pharmaceuticals ApS, Copenhagen, Denmark |
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Site registered |
EU GMP issued by Danish Medicines Agency US FDA Other health authorities |
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Batch size |
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Regulatory documentation |
EU dossier (filing Q1, 2024) US dossier |
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Packaging sizes |
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Shelf life |
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Storage conditions |
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