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;
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