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Intas Pharmaceutical Gets CDSCO Panel Nod to Study Atorvastatin plus Fenofibrate FDC

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-17T17:30:51+05:30  |  Updated On 17 July 2024 5:30 PM IST
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide
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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.

This came after Intas Pharmaceutical presented Protocol No. 0346-22, version 01, dated 19, 2024, and Protocol No.0012-24, version 01, dated 19-1-2024.

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.

At the recent SEC meeting for cardiovascular held on June 12, 2024, the expert panel reviewed Protocol No.0346-22 version 01 dated 19-1-2024 and Protocol No.0012-24 version 01 dated 19-1-2024 presented by the drug maker Intas Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to carry out the BA/BE study for export purposes only.
Also Read:CDSCO Panel Approves AstraZeneca pharma's Protocol Amendment proposal to study Anifrolumab
intas pharmacdscoAtorvastatinFenofibratelipid-lowering drug
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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