Windlass Biotech gets CDSCO Panel Nod To Manufacture, Market Ezetimibe plus Atorvastatin Calcium tablet

This came after Windlas Biotech presented its proposal and justification for the clinical trial waiver before the committee.

The committee noted that the said FDC is already approved in the USA, Australia, etc.

Ezetimibe and atorvastatin combination is used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood.

Ezetimibe is among a novel class of selective cholesterol-absorption inhibitors. It is indicated to reduce total cholesterol, low-density lipoprotein (LDL), apolipoprotein B (apo B), and non-high-density lipoprotein (HDL) in patients with primary hyperlipidemia, mixed hyperlipidemia, familial hypercholesterolemia (HoFH), and homozygous sitosterolemia (phytosterolemia).

Ezetimibe inhibits the absorption of cholesterol from the small intestine and decreases the amount of cholesterol normally available to liver cells. The lower levels of cholesterol in the liver cells lead them to absorb more cholesterol from circulation thus lowering the levels of circulating cholesterol. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your intestines. High cholesterol can cause fatty deposits to form in your blood vessels which increases your risk of heart disease. Ezetimibe is used in patients who cannot control their cholesterol levels by diet and exercise alone.

Atorvastatin belongs to a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Atorvastatin competitively inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. By preventing the conversion of HMG-CoA to mevalonate, statin medications decrease cholesterol production in the liver. Atorvastatin also increases the number of LDL receptors on the surface of hepatic cells.

At the recent SEC meeting for Cardiovascular held on the 18th of January 2023, the expert panel reviewed the proposal presented by the drug major Windlas Biotech along with justification for CT waiver of the FDC Ezetimibe plus Atorvastatin Calcium tablet.

After detailed deliberation, the committee considered the request for Phase III CT waiver and recommended for grant of permission for manufacturing and marketing of the FDC with the condition to conduct the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee.

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