Last Updated on December 31, 2023 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.
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