NDAINJECTIONINJECTABLE
Approved
Dec 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
TRANDATE (labetalol hydrochloride) by Bel Air Pharmaceuticals is alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. Approved for severe hypertension, to lower blood pressure, hypertension. First approved in 1985.
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRANDATE (labetalol hydrochloride) is an injectable alpha- and beta-adrenergic blocking agent with a 1:7 alpha-to-beta blockade ratio used to lower blood pressure in severe hypertension. It provides rapid hemodynamic control through combined sympathetic blockade, making it a critical acute care intervention.
LOE Approaching
As a near-LOE injectable with minimal commercial metrics available, TRANDATE roles are contracting; expect consolidation of brand support functions and shift toward managed care and hospital-focused strategies.
Mechanism of Action
alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. In man, the ratio of alpha- to beta-blockade has been estimated to be approximately 1:7 following intravenous administration. Beta 2 -agonist activity has been demonstrated in animals with minimal beta 1 -agonist activity…
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.