NDAINTRAVENOUSSOLUTION
Approved
Jan 2022
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
5/8 — Partial
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE (daptomycin in sodium chloride) by Baxter International is 12. Approved for pneumonia, left-sided infective endocarditis due to s, complicated skin and 16 more indications. First approved in 2022.
Drug data last refreshed 9h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Daptomycin in 0.9% Sodium Chloride is a pre-filled IV formulation of daptomycin, a lipopeptide antibacterial agent that disrupts bacterial cell membranes. It is indicated for complicated skin and skin structure infections (cSSSI), S. aureus bacteremia including endocarditis, and pneumonia caused by susceptible gram-positive bacteria. The drug's mechanism correlates with AUC/MIC ratios, achieving steady-state by the third daily dose with linear pharmacokinetics across approved dosing ranges.
Peak14.5 years to LOE
Product at peak commercial stage under Baxter International sponsorship with formulation patent extending to 2041, supporting stable medium-term career opportunities in brand management and field operations.
Mechanism of Action
12.1 Mechanism of Action Daptomycin is an antibacterial drug [see ] . 12.2 Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.