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 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRANDATE (labetalol HCl) is an injectable antihypertensive combining alpha-1 and beta-adrenergic blocking activity (1:7 ratio) for rapid blood pressure reduction in severe hypertension. Approved in 1985, it remains a critical acute-care agent for hypertensive emergencies and intraoperative/postoperative blood pressure management. The dual mechanism—alpha blockade causing vasodilation plus beta blockade reducing heart rate and contractility—enables effective parenteral control when oral agents are insufficient.
LOE Approaching
As LOE approaches, TRANDATE faces commoditization pressure; brand teams will focus on differentiation via clinical outcomes data, institutional relationships, and hospital formulary optimization rather than growth initiatives.
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.