NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Dec 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
5/8 — Partial
CLONIDINE (clonidine) by Gen Pharmaceuticals is clinical pharmacology clonidine stimulates alpha-adrenoreceptors in the brain stem. Approved for hypertension, attention deficit hyperactivity disorder. First approved in 2009.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Clonidine is an oral extended-release antihypertensive suspension approved by the FDA in December 2009 and manufactured by Gen Pharmaceuticals. It works by stimulating alpha-adrenoreceptors in the brain stem, reducing sympathetic outflow and decreasing blood pressure, peripheral resistance, heart rate, and renal vascular resistance. The drug achieves peak antihypertensive effects within 2-4 hours of oral administration and is indicated for the treatment of hypertension. It remains an established therapy in the cardiovascular treatment landscape, though it represents an older mechanism in a crowded antihypertensive market.
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Mechanism of Action
CLINICAL PHARMACOLOGY Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous system and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. Clonidine hydrochloride…
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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.