Ajanta Pharma Gets CDSCO panel conditional Nod to Manufacture, Market Cardiovascular FDC Drug
New Delhi: Citing that the proposed FDC is already approved in higher strength, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Ajanta Pharma to manufacture and market the fixed-dose combination the cardiovascular drug Metoprolol Succinate 25mg (as extended-release tablet) plus Telmisartan 40mg plus Amlodipine 5mg Tablets after submission of data including dissolution data and justification for bioequivalence (BE) study waiver as per the BE Study guideline.
This came after Ajanta Pharma presented its proposal along with a clinical trial and bioequivalence (BE) study waiver before the committee.
Metoprolol is a beta-blocker used in the treatment of hypertension and angina and is used to reduce mortality due to myocardial infarction. Metoprolol is a beta-1-adrenergic receptor inhibitor specific to cardiac cells with negligible effect on beta-2 receptors. This inhibition decreases cardiac output by producing negative chronotropic and inotropic effects without presenting activity towards membrane stabilization nor intrinsic sympathomimetics.
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