J&J Gets CDSCO Panel Nod To Conduct Phase IV CT of Ustekinumab
New Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV trial of Ustekinumab Pre-filled syringes 45 mg/0.5 ml, 90 mg/ml and Single use vial 130 mg/...
New Delhi: In order to evaluate safety of Ustekinumab in Indian subjects with Crohn’s Disease (CD), pharmaceutical major, Johnson & Johnson has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV trial of Ustekinumab Pre-filled syringes 45 mg/0.5 ml, 90 mg/ml and Single use vial 130 mg/ 26 ml.
This came after the firm presented the protocol to conduct a Phase IV clinical trial titled “An Open Label, Multicenter, Phase IV Study of Ustekinumab to evaluate its safety in Indian subjects with Crohn’s Disease (CD)” vide protocol CNTO1275CRD4045".
After detailed deliberation, the committee recommended the approval of the presented Phase IV study protocol.
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