NDAORALTABLETPriority Review
Approved
Feb 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
Priority Review
FURADANTIN (nitrofurantoin) by Aurobindo Pharma is clinical pharmacology each nitrofurantoin capsule (monohydrate/macrocrystals) contains two forms of nitrofurantoin. First approved in 1953.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FURADANTIN (nitrofurantoin) is an oral antibacterial agent approved in 1953 for treating urinary tract infections (UTIs) and cystitis. It works by being reduced by bacterial enzymes to reactive intermediates that damage bacterial DNA and proteins. The formulation combines 25% macrocrystalline nitrofurantoin with 75% monohydrate in a gel-matrix for modified release.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); team focus likely shifting to generic optimization and lifecycle extension rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Started Oct 2022
100 enrolled
Recurrent Urinary Tract Infection
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Started Apr 2020
1,606 enrolled
Urinary Tract Infections
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Started Jan 2018
225 enrolled
Uncomplicated Urinary Tract InfectionCystitis
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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.