NDAINJECTIONINJECTABLE
Approved
Jun 1970
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
UNIPEN (nafcillin sodium) by Thayer Medical is clinical pharmacology in a study of five healthy adults administered a single 500 mg dose of nafcillin by intravenous injection over seven minutes, the mean plasma concentration of the drug was approximately 30 mcg/ml at 5 minutes after injection. Approved for the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. First approved in 1970.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNIPEN (nafcillin sodium) is a penicillinase-resistant penicillin antibiotic administered by injection for treatment of infections caused by penicillinase-producing Staphylococcus aureus. It works by inhibiting bacterial cell wall biosynthesis, exerting bactericidal action during active microbial multiplication. The drug is primarily eliminated via hepatic inactivation and biliary excretion rather than renal clearance.
LOE Approaching
As LOE approaches, the brand team will likely focus on maximizing existing market share and managing transition to generic competition through healthcare provider relationships.
Mechanism of Action
CLINICAL PHARMACOLOGY In a study of five healthy adults administered a single 500 mg dose of nafcillin by intravenous injection over seven minutes, the mean plasma concentration of the drug was approximately 30 mcg/mL at 5 minutes after injection. The mean area under the plasma…
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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.