CDSCO panel gives nod for Icosapent Ethyl Capsules

The committee noted that the drug product is already approved by USFDA and available for clinical use in the USA

333
CDSCO Panel
CDSCO Panel

Last Updated on October 2, 2024 by The Health Master

Icosapent Ethyl Capsules 500mg and 1000mg, which are indicated as an adjunct therapy for severe hypertriglyceridemia, have been manufactured and marketed by the pharmaceutical company BDR Pharma with the approval of the CDSCO’s Subject Expert Committee (SEC).

The firm must submit postmarketing surveillance (PMS) data to CDSCO after marketing the drug product in the Indian market, though, as a condition of this approval.

This occurred after the company presented the committee with its proposal for the production and sale of icosapent ethyl capsules in dosages of 500 mg and 1000 mg for the use as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500 mg/dl and to lower the risk of a cardiovascular event in some patients with elevated triglycerides).

Patients with severe hypertriglyceridemia are treated with icosapent ethyl, an ethyl ester of eicosapentaenoic acid (EPA), which decreases triglyceride synthesis and increases triglyceride clearance.

In adult patients with elevated triglycerides (150 mg/dL) and established cardiovascular disease or who have diabetes mellitus and at least two other risk factors for cardiovascular disease, icosapent ethyl is recommended as an adjunct to maximally tolerated statin therapy to lower the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina necessitating hospitalization.

It is also recommended as a supplement to diet in adult patients with severe (500 mg/dL) hypertriglyceridemia to lower triglyceride levels.

Icosapent Ethyl Capsules 500mg and 1000mg were proposed by the pharmaceutical company BDR Pharma for manufacture and marketing with the following indications: “used as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500mg/dl and to reduce the risk of a cardiovascular event in certain patients with elevated triglycerides”) and with BE and CT waiver justification. The proposal was reviewed by the expert panel at the recent SEC meeting for the

The committee noted that the drug product is already approved by USFDA and available for clinical use in the USA

After careful deliberation, the committee recommended that the firm submit PMS data to CDSCO after marketing the drug product in the Indian market in order to receive permission to manufacture and market the applied drug product for the suggested indication.

CDSCO Panel nod for Cholecalciferol Aqueous Injection

CDCSO Panel gives nod to market for Ocrelizumab

CDSCO panel gives nod for BE study of Tadalafil Oral Jelly

CDSCO Panel gives nod Clinical Trial for this Anticancer Drug

CDSCO Panel gives nod for FDC Tamsulosin + Solifenacin

CDSCO panel gives nod for Esomeprazole Dual Release Gastro resistant Tablets

NPPA decided to address the issue of inter brand price variation

FDA Haryana: Medical store sealed, drugs being sold at prices higher than MRP

USFDA gives nod for Aflibercept injection to treat infants with prematurity issue

Pharma employee held by Mumbai police in spurious injection case

Health officials warn of norovirus spike in England

Dissolution test: Importance in Pharma Industry

Updated list of Medical Device Testing Laboratories (MDTLs)

Lux level in Industry (Pharma, Cosmetics, Homeopathy & Medical Devices)

Aerosols in Cosmetics

Latest Notifications regarding Pharmaceuticals

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news