Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet

This came after Akum Pharmaceuticals presented the raw data of the Phase III clinical trial report before the committee.

Azelnidipine is a calcium channel blocker (dihydropyridine calcium channel blocker). It is used in the treatment of Hypertension (high blood pressure). It regulates blood pressure by relaxing the blood vessels and reducing the pressure on them, thereby making it easier for the heart to pump more blood throughout the body. In this way, it normalizes the blood pressure in patients with high blood pressure.

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.

Metoprolol is used alone or in combination with other medications to treat high blood pressure. It also is used to treat chronic (long-term) angina (chest pain). Metoprolol is also used to improve survival after a heart attack. Metoprolol also is used in combination with other medications to treat heart failure.

At the recent SEC meeting for Cardiovascular and Renal held on 22 November 2023, the expert panel reviewed the raw data of the Phase III clinical trial of the FDC Azelnidipine plus Metoprolol Succinate film coated bilayered tablet

After detailed deliberation, the committee recommended a grant of permission for the manufacturing and marketing of the proposed FDC.

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