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 13h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNIPEN (nafcillin sodium) is a penicillinase-resistant penicillin antibiotic approved in 1973 for treating infections caused by penicillinase-producing Staphylococcus aureus. It works by inhibiting bacterial cell wall biosynthesis and exhibits bactericidal activity during active microbial multiplication. Available as an oral tablet, nafcillin is primarily eliminated via hepatic inactivation and bile excretion rather than renal clearance, making it useful in patients with renal impairment.
LOE Approaching
As a legacy antibiotic approaching loss of exclusivity with minimal ongoing development activity, career growth is limited to commercial maintenance or defensive positioning.
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.