NDAINJECTIONINJECTABLEPriority Review
Approved
Aug 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
NORMODYNE (labetalol hydrochloride) by Merck & Co. is alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. Approved for severe hypertension, to lower blood pressure, hypertension. First approved in 1984.
Drug data last refreshed 11h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Normodyne (labetalol HCl) is an injectable antihypertensive agent with combined alpha-1 and beta-adrenergic blocking activity, used to treat severe hypertension and rapidly lower blood pressure in acute settings. The drug's dual mechanism—approximately 1:7 alpha-to-beta blockade ratio—allows for vasodilation and heart rate reduction simultaneously.
LOE Approaching
As lifecycle approaches expiry, brand team likely consolidating—expect reduced headcount in commercial roles and shift toward line extension or exit strategy.
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.