NDAORALSOLUTION
Approved
May 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
PEDIAPRED (prednisolone sodium phosphate) by Alcon is clinical pharmacology naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. First approved in 1986.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEDIAPRED (prednisolone sodium phosphate) is a synthetic glucocorticoid oral solution approved for multiple sclerosis and other inflammatory conditions. It works by suppressing inflammatory processes, inhibiting immune cell production, and promoting gluconeogenesis through potent anti-inflammatory mechanisms. The oral solution formulation achieves 14% higher peak plasma levels 20% faster than tablet formulations, enabling rapid therapeutic response in acute episodes.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on lifecycle extension and transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many…
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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.