CDSCO Panel Gives Conditional nod to Azelnidipine and Olmesartan FDC

This came after manufacturer Akum Drugs applied to the SEC committee for permission for FDC of Azelnidipine IP + Olmesartan Medomoxil IP (8mg/8mg/8mg +10mg/20mg/40mg) film-coated tablet

The Subject Expert Committee (SEC) of CDSCO, approved the manufacturing and marketing of the FDC of Azelnidipine IP + OlmesartanMedomoxil IP (8mg/8mg + 20mg/40mg) subject to some conditions. SEC also recommended the Firm to prepare a BE study report on the lower strength (Olmesartan Medomoxil IP 10 mg) before getting the nod for the same.

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Azelnidipine is known for its usage in the treatment of Hypertension. Azelnidipine, which is a calcium channel blocker, helps regulate blood pressure by relaxing the blood vessels and reducing the pressure in them.

Olmesartan Medomoxil is also a drug used in the treatment of Hypertension. It also acts as a preventive for heart failure and stroke.

The SEC committee, in its 83^rd meeting, held on 07.01.2021 & 08.01.2021 at CDSCO HQ New Delhi discussed all the Cardiovascular and Renal proposals and made some recommendations regarding the same.

While reviewing the proposal of Akum Drugs the Committee noted that FDC of Azelnidipine IP + Olmesartan Medomoxil IP (8mg/8mg + 20mg/40mg) film-coated tablet is already approved by CDSCO. The firm, Akum Drugs, presented the report of the BE study conducted on the higher strength and requested for clinical trial waiver w.r.t. the lower strength.

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After detailed deliberation, Committee recommended for grant of permission for manufacturing and marketing the FDC of Azelnidipine IP + Olmesartan Medomoxil IP (8mg/8mg + 20mg/40mg) subject to the condition that firm should submit comparative analysis including in-vitro dissolution studies with the approved FDCs to CDSCO.

Further as regard to the FDC of Azelnidipine IP + Olmesartan Medomoxil IP (8mg + 10mg) film-coated tablet, committee noted the claim of the firm that the same strength is already approved in Japan. The committee considered the request of the firm for a clinical trial waiver and recommended that the firm should conduct a BE study comparing their product with the lower strength already approved in Japan before considering the approval. Accordingly, the firm should submit the BE study protocol for review by the Committee.

Akums is a Contract Research and Manufacturing (CRAMS) organization responsible for manufacturing approximately 11-12 % of all drugs consumed in the country, as per its website. 

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