NDAORALTABLET, EXTENDED RELEASE
Approved
Apr 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
ADALAT CC (nifedipine) by Charter Medical is clinical pharmacology nifedipine is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) which inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. First approved in 1993.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADALAT CC (nifedipine) is an extended-release oral calcium channel blocker approved in 1993 for hypertension and angina management. It works by inhibiting calcium ion influx into vascular smooth muscle and cardiac muscle, causing peripheral arterial vasodilation and reduced vascular resistance. The extended-release formulation provides sustained plasma concentrations with a ~7-hour half-life, enabling once-daily dosing compared to immediate-release alternatives.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating team focus is shifting toward managed decline and generic transition strategies rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Nifedipine is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) which inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. The contractile processes of vascular smooth muscle and cardiac muscle are…
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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.