Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has directed Zydus Healthcare Ltd. to conduct a Phase IV clinical trial only for the strengths intended to be marketed for its combination product of Empagliflozin + Metformin Hydrochloride (Extended Release). The committee further recommended that the firm withdraw the remaining strengths from the permission granted.
The recommendations came in response to the firm’s submission of a Phase IV clinical trial protocol involving Empagliflozin 10 mg + Metformin Hydrochloride (Extended Release) 1000 mg tablets. According to the protocol, participants requiring additional glycemic control may be administered Empagliflozin 25 mg + Metformin ER 1000 mg tablets.
After detailed deliberation, the committee recommended that;
"the firm should conduct Phase IV clinical trial for all the strengths intended to be marketed and withdraw the remaining strengths from the permission.”
Further, the committee directed the firm to clarify which strengths are to be marketed, and submit the Phase IV clinical trial protocol to CDSCO accordingly. Once the protocol is approved, the firm must submit the trial report for further review by the SEC.
"Accordingly, firm should submit Phase IV clinical trial protocol after clarification of remaining strengths to CDSCO. After approval from CDSCO, the firm should submit Phase IV clinical trial report for further review by the committee," the expert panel said.
This recommendation follows the condition mentioned in the company’s earlier Form CT-23 approval dated 13.12.2024
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