NDAORALGRANULE
Approved
Nov 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
PEDIAZOLE (erythromycin ethylsuccinate; sulfisoxazole acetyl) by Teva is clinical pharmacology: orally administered erythromycin ethylsuccinate suspensions are readily and reliably absorbed. Approved for the following infections caused by chlamydia trachomatis : conjunctivitis of the newborn, pneumonia of infancy, urogenital infections during pregnancy and 8 more indications. First approved in 1979.
Drug data last refreshed 16h ago · AI intelligence enriched 19h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEDIAZOLE is an oral combination antibiotic containing erythromycin ethylsuccinate and sulfisoxazole acetyl, approved in 1979 for treating infections caused by Chlamydia trachomatis, Ureaplasma urealyticum, and other respiratory pathogens. Erythromycin inhibits bacterial protein synthesis by binding to 50S ribosomal subunits, while sulfisoxazole provides broad-spectrum coverage. This fixed-dose combination is particularly indicated for pediatric infections and penicillin-allergic patients.
LOE Approaching
Product approaching loss of exclusivity with declining competitive pressure (30%) suggests contracting team size and focus on cost management over growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY: Orally administered erythromycin ethylsuccinate suspensions are readily and reliably absorbed. Erythromycin ethylsuccinate products have demonstrated rapid and consistent absorption in both fasting and nonfasting conditions. However, higher serum concentrations are obtained…
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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.