Submit Justification: CDSCO Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug

This came after the firm presented the proposal before the committee along with details of study sites and raw data of clinical trial study results.

Azelnidipine is a calcium channel blocker. 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. Azelnidipine is used in the treatment of Hypertension (high blood pressure).

Azelnidipine inhibits trans-membrane Ca2+ influx through the voltage-dependent channels of smooth muscles in vascular walls. Ca2+ channels are classified into various categories, including L-type, T-type, N-type, P/Q-type, and R-type Ca2+ channels. The L-type Ca2+ channels.

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.

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 through negative inotropic and chronotropic effects.

At the recent SEC meeting for Cardiovascular and Renal held on 7th June 2023, the expert panel reviewed the proposal for conducting the study of the FDC cardiovascular drug along with details of study sites as well as raw data of clinical trial study results.

The committee noted that the results presented were not validated and were clinically untenable.

After detailed deliberation, the committee recommended that the firm should submit detailed clarification/justification to CDSCO for further review by the committee.

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