TRANDATE
LOE ApproachingNDAORALTABLET
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
TRANDATE by Alvogen is clinical pharmacology labetalol hcl combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. Approved for the management of hypertension. First approved in 1984.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRANDATE is an oral tablet small-molecule antihypertensive agent approved in 1984 by the FDA. The generic name is labetalol, a combined alpha and beta-adrenergic blocker used to treat hypertension. It works by blocking both alpha and beta-adrenergic receptors, reducing peripheral vascular resistance and heart rate to lower blood pressure.
LOE Approaching
With LOE approaching, the brand is in transition; expect consolidation of commercial headcount and shift toward generic/authorized generic strategy rather than branded promotion.
Mechanism of Action
CLINICAL PHARMACOLOGY Labetalol HCl combines both selective, competitive, alpha 1 -adrenergic blocking and nonselective, competitive, beta-adrenergic blocking activity in a single substance. In man, the ratios of alpha- to beta-blockade have been estimated to be approximately 1:3 and 1:7 following…
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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.