BDR Pharma gets CDSCO panel nod to Manufacture, Market Icosapent Ethyl Capsules
New Delhi: The drug maker BDR Pharma has got approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the lipid-regulating agent Icosapent Ethyl Capsules 500mg and 1000mg indicated for an adjunct therapy for severe hypertriglyceridemia.
However, this approval is subject to a condition that the firm should submit postmarketing surveillance (PMS) data to CDSCO after marketing the drug product in the Indian market.
This came after the firm presented its proposal for the manufacture and marketing of Icosapent Ethyl Capsules 500mg and 1000mg for the indication “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)” along with bioequivalence (BE) and clinical trial (CT) waiver justification before the committee.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.