NDAORALTABLET
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
6/8 — Strong
EDARBYCLOR (azilsartan kamedoxomil and chlorthalidone) by R-Pharm US is regulation. Approved for hypertension, to lower blood pressure: in patients not adequately controlled with monotherapy ( ), nonfatal cardiovascular events and 6 more indications. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDARBYCLOR is a fixed-dose combination tablet containing azilsartan kamedoxomil (an angiotensin II receptor blocker) and chlorthalidone (a thiazide-like diuretic), approved in December 2011. It is indicated for hypertension management in patients not adequately controlled with monotherapy, with demonstrated efficacy in reducing nonfatal cardiovascular events including strokes and myocardial infarctions. The dual mechanism works by blocking angiotensin II-mediated vasoconstriction while simultaneously promoting sodium and water excretion, providing complementary blood pressure reduction. EDARBYCLOR occupies a well-established position in the antihypertensive combination therapy landscape, competing primarily with other ARB/diuretic and ACE inhibitor/diuretic fixed-dose combinations.
$0.0BPart D
5.2 years to LOEMechanism of Action
regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of…
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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.