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