New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN Laboratories to conduct a Phase IV clinical trial of Tofacitinib Oral Solution 1 mg/ml.

However, the nod is subject to the condition that the dosing regimen shall be stratified across at least two distinct age groups and accordingly, statistical evaluation shall be performed to assess agespecific responses and dosing appropriateness.

Furthermore, it added, that in exclusion criteria, Latent Tuberculosis Infection (LTBI) shall be incorporated as part of the clinical protocol.

This came after MSN Laboratories presented the proposal for grant of permission to conduct Phase IV Clinical Trial Protocol vide protocol No. 010/TFCB-OS/MSN/2025, Vers

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