NDAORALTABLET3 Generics Approved
Approved
Jul 1992
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
14
Data completeness
3/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORVASC (amlodipine besylate) is an oral calcium channel blocker approved in 1992 for hypertension and angina. It works by inhibiting calcium ion influx into vascular smooth muscle and cardiac muscle, causing peripheral vasodilation and reducing blood pressure and myocardial oxygen demand. The drug selectively acts on vascular smooth muscle with minimal effects on cardiac contractility at therapeutic doses.
$0.016BPart D
LOE ApproachingDeclining
As LOE approaches, brand team focus shifts from growth to lifecycle extension and generic-to-brand transition management; smaller teams emphasize efficiency.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Started May 2018
36 enrolled
Hypertension
Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
Started Dec 2016
99 enrolled
Hypertension
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Started Oct 2011
80 enrolled
Healthy
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Started Sep 2011
90 enrolled
Healthy
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Started May 2010
18 enrolled
Healthy Volunteers
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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.