NDAINTRAVENOUSPOWDER
Approved
Apr 2015
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
3/8 — Basic
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER (meropenem and sodium chloride) by B. Braun is 12. Approved for complicated skin, skin structure infections (csssi) due to staphylococcus aureus (methicillin-susceptible isolates only), streptococcus pyogenes and 14 more indications. First approved in 2015.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Meropenem and sodium chloride in duplex container is a ready-to-use IV carbapenem antibiotic combination indicated for complicated skin and skin structure infections, complicated appendicitis, peritonitis, and bacterial meningitis caused by susceptible gram-positive and gram-negative organisms. Meropenem works by inhibiting bacterial cell wall synthesis, with efficacy best correlated to the time plasma concentration exceeds the organism's minimum inhibitory concentration. The duplex container format enables point-of-use mixing without additional manipulation.
Peak
Product is in peak commercial phase with established market presence; marketing teams focus on hospital formulary relationships and prescriber loyalty rather than rapid growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Meropenem is an antibacterial drug [see ]. 12.2 Pharmacodynamics The percentage of time of a dosing interval that unbound plasma concentration of meropenem exceeds the meropenem minimum inhibitory concentration (MIC) against the infecting organism has been shown to best…
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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.