Zydus Healthcare gets CDSCO Panel Nod To study FDC Empagliflozin plus Metoprolol Succinate

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-10T17:45:16+05:30 | Updated On 21 March 2024 9:18 PM IST

Delhi HC grants relief to zydus healthcare in biochem trademark case

New Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) Empagliflozin 10mg/10mg plus Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (ER) 25mg/ Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (ER) 50mg uncoated bilayered tablet.

This came after Zydus Healthcare presented its proposal and BE study protocol before the committee.

Empagliflozin is a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medication for diabetes. Empagliflozin can also be used to treat heart failure. It can reduce the risk of your heart getting weaker, and help symptoms such as tiredness. Empagliflozin is only available on prescription.

Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal glucose reabsorption and increases urinary excretion.

Metoprolol is a cardioselective beta-1-adrenergic receptor inhibitor that competitively blocks beta1 receptors with minimal or no effects on beta-2 receptors at oral doses of less than 100 mg in adults. It decreases cardiac output by negative inotropic and chronotropic effects.

At the recent SEC meeting for Cardiovascular on 20th February 2024, the expert panel reviewed the proposal presented by the drug major Zydus Healthcare along with the BE study protocol of the FDC Empagliflozin plus Metoprolol Succinate.

After detailed deliberation, the committee recommended a grant of permission to conduct the BE Study.

Accordingly, the expert panel suggested that the firm should submit a BE study report for review by the committee and for taking further decisions on the Phase III clinical trial protocol.

Also Read:Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets

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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-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