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.
Telmisartan is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as telmisartan bind to the angiotensin II type 1 (AT1) receptors with high affinity, causing inhibition of the action of angiotensin II on vascular smooth muscle, ultimately leading to a reduction in arterial blood pressure.
Amlodipine is a calcium channel blocker used to treat hypertension and angina. Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
At the recent SEC meeting for Cardiovascular and Renal held on 9th August 2023, the expert panel reviewed the proposal presented by Ajanta Pharma for the FDC Metoprolol Succinate 25mg (as an extended-release tablet) plus Telmisartan 40mg plus Amlodipine 5mgTablets.
The committee noted that the proposed FDC is already approved in higher strength i.e. FDC of Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended-release tablet) 50 mg plus Telmisartan IP 40mg plus Amlodipine Besilate IP eq. to Amlodipine 5mg Tablets.
After detailed deliberation, the committee recommended granting permission to manufacture and market the product after submission of data including dissolution data and justification for BE waiver as per the BE Study guideline.
Also Read:CDSCO Panel Rejects Dr. Reddy's Proposal For Ketorolac Tromethamine plus Serratiopeptidase FDC
