New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Zydus Lifesciences Ltd to revise and resubmit the Phase IV Clinical Trial protocol for Letermovir Tablets 240 mg and 480 mg after incorporating the committee's specific recommendations regarding sample size, study endpoints, and coverage of all approved indications.

As per the minutes of the SEC (Antimicrobial & Antiviral) meeting held on 16th September 2025, the firm presented the Phase IV Clinical Trial protocol of Letermovir Tablets 240 mg and 480 mg, vide Protocol No. C2B05804, Version 1.0 (dated 28.05.2025), before the committee. The submission was made in line with the condition of the earlier permission granted for the manufacture and marketing of the drug.

The

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