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 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEDIAZOLE is an oral granule combination antibiotic containing erythromycin ethylsuccinate and sulfisoxazole acetyl, approved in 1979. It treats Chlamydia trachomatis infections (conjunctivitis in newborns, pneumonia, urogenital infections), nongonococcal urethritis, and is indicated for penicillin-allergic patients with susceptible bacterial infections. The combination works through dual mechanisms: erythromycin inhibits protein synthesis by binding 50S ribosomal subunits, while sulfisoxazole acts as a sulfonamide antibiotic.
LOE Approaching
PEDIAZOLE is approaching loss of exclusivity with minimal current spending visibility, signaling a contracting commercial footprint and likely reduced team investment.
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.