NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Jun 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
Priority Review
AZULFIDINE EN-TABS (sulfasalazine) by Pfizer is clinical pharmacology pharmacodynamics the mode of action of sulfasalazine (ssz) or its metabolites, 5-aminosalicylic acid (5-asa) and sulfapyridine (sp), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its affinity for connective tissue, and/or to the relatively high concentration it reaches in serous fluids, the liver and intestinal walls, as demonstrated in autoradiographic studies in animals. Approved for rheumatoid arthritis, psoriatic arthritis, juvenile rheumatoid arthritis. First approved in 1950.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AZULFIDINE EN-TABS (sulfasalazine) is an oral aminosalicylate approved in 1950 for rheumatoid arthritis, psoriatic arthritis, and juvenile rheumatoid arthritis. It works through anti-inflammatory and immunomodulatory mechanisms, with its active metabolite 5-ASA concentrating in intestinal walls and serous fluids to suppress disease activity.
LOE Approaching
This product is approaching loss of exclusivity with limited remaining patent protection, signaling a smaller brand team focused on patient retention rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics The mode of action of sulfasalazine (SSZ) or its metabolites, 5-aminosalicylic acid (5-ASA) and sulfapyridine (SP), may be related to the anti-inflammatory and/or immunomodulatory properties that have been observed in animal and in vitro models, to its…
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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.