NDAORALTABLET
Approved
Aug 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
113
Data completeness
6/8 — Strong
CRESTOR (rosuvastatin) by AstraZeneca is hmg‑coa reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme a to mevalonate, a precursor of cholesterol. Approved for hypercholesterolemia, dyslipidemia, hyperlipidemia and 2 more indications. First approved in 2003.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CRESTOR (rosuvastatin) is an oral tablet HMG-CoA reductase inhibitor (statin) approved by the FDA on August 12, 2003, and marketed by AstraZeneca. It works by inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. CRESTOR is indicated for cholesterol management and cardiovascular risk reduction in patients with dyslipidemia. As a mature statin class drug, it competes in a crowded but essential therapeutic category for primary and secondary prevention of cardiovascular disease.
$0.0BPart D
Mechanism of Action
HMG‑CoA reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.
Indications (5)
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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.