NDAORALTABLETPriority Review
Approved
Feb 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
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 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Nitrofurantoin (FURADANTIN) is an oral antibiotic indicated for urinary tract infections, utilizing a dual-release formulation combining 75% monohydrate (gel-matrix) and 25% macrocrystals for optimized urinary drug delivery. The drug works by inhibiting bacterial enzymes essential for cell wall synthesis, achieving high urinary concentrations while maintaining low systemic plasma levels. It has been the standard-of-care agent for uncomplicated UTIs since its FDA approval in 1953.
LOE Approaching
As a mature, off-patent product with LOE approaching, the brand team is likely focused on generic defense and cost-containment strategies rather than expansion.
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 (6)
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
Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg
Started Sep 2003
28 enrolled
Healthy
Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
Started Oct 2002
71 enrolled
Healthy
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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.