NDAORALTABLET
Approved
Oct 1973
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 1973.
Drug data last refreshed 1h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNIPEN (nafcillin sodium) is a penicillinase-resistant penicillin antibiotic administered orally as a tablet. It treats infections caused by penicillinase-producing Staphylococcus aureus (methicillin-susceptible isolates only) by inhibiting bacterial cell wall biosynthesis.
LOE Approaching
Product approaching loss of exclusivity; brand teams should anticipate portfolio transition planning and possible resource reallocation.
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.