NDAINJECTIONINJECTABLE
Approved
Apr 1955
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SOLU-CORTEF (hydrocortisone sodium succinate) by Pfizer is clinical pharmacology glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. First approved in 1955.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SOLU-CORTEF is a water-soluble, rapid-acting injectable glucocorticoid (hydrocortisone sodium succinate) that provides immediate anti-inflammatory and immunomodulatory effects. It is indicated for acute hematologic malignancies including Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Juvenile Myelomonocytic Leukemia. The drug works by binding glucocorticoid receptors to suppress immune response and reduce inflammation, with demonstrable effects within one hour and near-complete excretion within 12 hours.
$0.674MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D utilization (9,502 claims); brand teams should anticipate shrinking headcount and transition to generic/commodity positioning.
Mechanism of Action
CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.