NDAINTRAVENOUSPOWDER
Approved
Sep 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
DAPTOMYCIN (daptomycin) by Sagent Pharmaceuticals is [see clinical pharmacology ()] . First approved in 2017.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Daptomycin is a lipopeptide antibiotic administered intravenously as a powder for reconstitution. It is used to treat serious infections caused by gram-positive bacteria, including skin infections and bloodstream infections. The drug works by binding to bacterial cell membranes and causing rapid depolarization, leading to cell death.
$0.692MPart D
PeakProduct is at peak lifecycle stage with moderate commercial activity; commercial team focus is on maintaining market position against 30% competitive pressure.
Mechanism of Action
[see Clinical Pharmacology ()] .
Pharmacologic Class:
Lipopeptide Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
Started Dec 2018
18 enrolled
BacteremiaSoft Tissue InfectionsSkin Diseases, Infectious
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
Started May 2014
12 enrolled
Drug InteractionsPharmacokinetics
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
Started Sep 2013
149 enrolled
Acute Hematogenous Osteomyelitis
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
Started Nov 2012
82 enrolled
Bacteremia
Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia
Started May 2012
10 enrolled
Nosocomial InfectionHealthcare-associated Infection
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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.