Submit raw data linked to CT result: CDSCO Panel Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug
New Delhi: Based on the justification presented by Akum Pharmaceutical with respect to the clinical trial results of the fixed-dose combination (FDC) drug Azelnidipine plus Metoprolol, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the raw data of the clinical trial.
This came after the firm presented its proposal along with clarification/justification with respect to clinical trial results of the FDC cardiovascular drug Azelnidipine 8mg/8mg/16mg/16mg)plus Metoprolol (25mg/ 50mg/25mg/50mg) sustained released (SR) tablet.
In continuation, at the recent SEC meeting for the Cardiovascular and renal held on 11 October 2023, the expert panel reviewed the proposal presented by Akum Pharmaceuticals along with clarification or justification with respect to clinical trial results of the FDC Azelnidipine plus Metoprolol (SR) tablet.
After detailed deliberation, the committee opined that the firm should submit raw data from the clinical trial to the CDSCO for review by the committee.
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