Last Updated on January 9, 2024 by The Health Master
New Delhi: Exemed Pharmaceuticals 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 proposed fixed dose combination drug (FDC) for the higher strength only, which is Atorvastatin Calcium 80mg plus Bempedoic acid 180mg tablets to treat hypercholesterolemia.
However, the approval is subjected to a condition that the drug maker is required to submit a Phase IV clinical trial protocol within 3 months from the date of approval.
This came after the firm presented the bioequivalence report of the FDC of Bempedoic acid plus Atorvastatin Calcium to treat hypercholesterolemia.
In addition, the firm also presented the Phase III clinical trial data generated with the concomitant use of Atorvastatin and Bempedoic acid.
At the recent SEC meeting for Cardiovascular and Renal held on September 7th, 2022, the expert panel reviewed the bioequivalence report and the Phase III clinical trial data of the FDC of Bempedoic acid plus Atorvastatin Calcium.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and marketing of the proposed FDC for the higher strength only, i.e., Atorvastatin Calcium eq. to Atorvastatin 80mg + Bempedoic acid 180mg tablets with the condition to submit the Phase IV clinical trial protocol within 3 months from the date of approval.
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