Intas Pharmaceutical Gets CDSCO Panel Nod to Study Atorvastatin plus Fenofibrate FDC
New Delhi: The drug major Intas Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioavailability/bioequivalence (BA/BE) study of the fixed-dose combination (FDC) of atorvastatin plus fenofibrate tablets (40+145) mg.
Atorvastatin plus Fenofibrate belongs to the class of medicines called antilipemics (lipid-lowering medicines) primarily used in the treatment of high lipid levels (cholesterol and triglyceride levels) and prevention of heart diseases and blood vessel blockage.
Bioavailability and bioequivalence studies are required to ensure therapeutic equivalence between a pharmaceutically equivalent test drug and a generic drug or reference drug.
Atorvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works by blocking an enzyme that is needed by the body to make cholesterol, and this reduces the amount of cholesterol in the blood. Atorvastatin is used together with a proper diet to lower cholesterol and triglyceride (fat) levels in the blood. This medicine may help prevent medical problems (eg, chest pain, heart attack, or stroke) that are caused by fats clogging the blood vessels.
Fenofibrate is a peroxisome proliferator receptor alpha activator used to lower LDL-C, total-C, triglycerides, and Apo B while increasing HDL-C in hypercholesterolemia, dyslipidemia, and hypertriglyceridemia. Fenofibrate activates peroxisome proliferator-activated receptor alpha (PPARα), increasing lipolysis, activating lipoprotein lipase, and reducing apoprotein C-III. PPARα is a nuclear receptor and its activation alters lipid, glucose, and amino acid homeostasis.
