NDAORALSUSPENSION
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
FLOLIPID (simvastatin) by Engine Biosciences is hydroxymethylglutaryl-coa reductase inhibitors [moa]. Approved for hypercholesterolemia, dyslipidemia, mixed dyslipidemia and 3 more indications. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOLIPID is an oral suspension formulation of simvastatin, a statin that inhibits HMG-CoA reductase to lower cholesterol and reduce cardiovascular risk. It is indicated for hypercholesterolemia, dyslipidemia, coronary heart disease, and multiple cardiometabolic and inflammatory conditions. The drug works by blocking a key enzyme in cholesterol synthesis, reducing LDL cholesterol and triglycerides.
$5KPart D
Peak3.8 years to LOEVery limited Part D footprint ($5K annual spending) suggests niche positioning or poor market penetration; modest team size expected.
Mechanism of Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Indications (6)
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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.