NDAORALTABLETPriority Review
Approved
Jun 1950
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
6/8 — Strong
Priority Review
AZULFIDINE (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. First approved in 1950.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Azulfidine (sulfasalazine) is an oral small-molecule aminosalicylate approved in 1950 for treating rheumatoid arthritis, inflammatory bowel disease, and related inflammatory conditions. It works through anti-inflammatory and immunomodulatory mechanisms, with its active metabolite 5-ASA delivering therapeutic benefit primarily in the intestine and connective tissue.
$272KPart D
LOE ApproachingDeclining
Minimal spending ($272K) and claim volume signal a mature, declining product with likely small brand team focused on defending market share against newer agents.
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.