NDAORALSUSPENSION
Approved
Dec 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
FURADANTIN (nitrofurantoin) by R-Pharm US is 12. First approved in 1953.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FURADANTIN (nitrofurantoin) is a nitrofuran antibacterial drug approved in 1953 for urinary tract infections and asymptomatic bacteriuria in pregnancy. It works by being reduced by bacterial enzymes to reactive intermediates that damage bacterial DNA and proteins. The drug is rapidly absorbed orally and highly concentrated in urine with minimal systemic distribution.
LOE Approaching
As a product approaching loss of exclusivity with moderate competitive pressure (30), R-Pharm US faces team right-sizing and transition planning toward generic defense or niche positioning.
Mechanism of Action
12.1 Mechanism of Action Nitrofurantoin is an antibacterial drug [ see ]. 12.2 Pharmacodynamics Pharmacodynamic effects of nitrofurantoin are unknown. 12.3 Pharmacokinetics Absorption Orally administered nitrofurantoin is readily absorbed. Blood concentrations at therapeutic dosage are usually low.…
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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.