Ajanta Pharma gets CDSCO Panel Nod to manufacture, market high blood pressure FDC drug
New Delhi: Ajanta Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the fixed-dose combination (FDC) Metoprolol Succinate IP 47.50 mg eq to Metoprolol Tartrate (as an extended-release tablet) plus Telmisartan IP 40mg plus Amlodipine film coated bi-layered tablet, which is used to treat high blood pressure.
This came after the firm presented a bioequivalence (BE) study report and Phase III clinical trial study of the FDC Metoprolol Succinate IP 47.50 mg eq to Metoprolol Tartrate (as an extended-release tablet) plus Telmisartan IP 40mg plus Amlodipine film coated bilayered tablet report before the Committee.
Metoprolol is in a class of medications called beta-blockers. Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is used to prevent angina (chest pain) and to improve survival after a heart attack. Metoprolol also is used in combination with other medications to treat heart failure.
Amlodipine is an oral dihydropyridine calcium channel blocker. Amlodipine works by blocking the voltage-dependent L-type calcium channels, thereby inhibiting the initial influx of calcium. Compared to nifedipine and other medications in the dihydropyridine class, amlodipine has the longest half-life at 30 to 50 hours.
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).
Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
Telmisartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, telmisartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is also used to decrease the chance of heart attack, stroke, or death in people 55 years of age or older who are at high risk for cardiovascular disease.
At the recent SEC meeting, Cardiovascular & Renal held on 10th May 2023, the expert panel reviewed the BE study report and Phase III clinical trial study report of the FDC Metoprolol Succinate IP 47.50 mg eq to Metoprolol Tartrate (as an extended-release tablet) plus Telmisartan IP 40mg plus Amlodipine film-coated bilayered tablet
After detailed deliberation, the committee considered the reports and recommended the grant of permission to manufacture & market the product.
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