CELESTONE
LOE ApproachingNDAORALSYRUP
Approved
Apr 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CELESTONE by Merck & Co. is clinical pharmacology glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Approved for dermatomyositis, polymyositis, systemic lupus erythematosus. First approved in 1964.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELESTONE (betamethasone) is a synthetic glucocorticoid approved in 1964 for preterm birth prevention. It works by enhancing anti-inflammatory action through a 16β-methyl group modification while reducing sodium and water retention. The oral syrup formulation provides prompt activity for maternal-fetal indications.
LOE Approaching
Product approaching loss of exclusivity with limited commercial team opportunity; focus likely on defending market share against generic erosion.
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 (3)
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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.