NIFEDIPINE

Post-LOESM

nifedipine

Charter Medical

ANDAORALCAPSULE

Approved

Oct 1991

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

NIFEDIPINE (nifedipine) by Charter Medical is calcium channel antagonists [moa]. Approved for vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by st segment elevation, 2) angina, coronary artery spasm provoked by ergonovine and 4 more indications. First approved in 1991.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

Calcium Channel Antagonists

Pharmacologic Class:

Dihydropyridine Calcium Channel Blocker

Indications (7)

vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation 2) angina

Worked on NIFEDIPINE at Charter Medical? Share your interview experience or compensation data (+7 days Pro)

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.

Clinical Trials (20)

NCT02047019Phase 3Withdrawn

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil

Started Dec 2017

Hypertension

NCT03194633N/ACompleted

Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study

Started Jul 2017

871 enrolled

Hypertension

NCT03129945N/ACompleted

Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

Started Jan 2017

36 enrolled

Obstetric Labor, Premature

NCT02940548Phase 4Terminated

Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness

Started Dec 2016

99 enrolled

Hypertension

NCT02499822Phase 4Completed

REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial

Started Oct 2015

168 enrolled

HypertensionHigh Blood Pressure Variability