Zydus Told to Withdraw Unmarketed Strengths, Conduct Phase IV Trial for Approved Combinations Only
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-23 16:14 GMT | Update On 2025-05-23 16:14 GMT
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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.
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