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 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRANDATE (labetalol HCl) is an intravenous antihypertensive combining alpha-1 and beta-adrenergic blocking activity with a 1:7 alpha-to-beta ratio. It is indicated for severe hypertension and acute blood pressure reduction in hospitalized patients. The dual mechanism provides rapid, titratable hemodynamic control without reflex tachycardia.
LOE Approaching
As an older injectable reaching LOE, TRANDATE likely supports a small, maintenance-focused team focused on hospital formulary retention and generic transition management.
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.