CDSCO panel nod to Novartis Ruxolitinib for acute and chronic graft versus host disease
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In response to the pharma major Novartis proposal for additional indication of Ruxolitinib Tablets 5/10/15/20 mg, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has granted permission for additional indication of Ruxolitinib for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.
This nod is subjected to condition that the firm should submit safety and efficacy data of ongoing Global study and Post Marketing data related to said indication within one year from the approval for evaluation by the committee for its continued marketing.
For more details, check out the full story on the link below:
Novartis Ruxolitinib Gets CDSCO Panel Okay For Acute And Chronic Graft Versus Host Disease
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