New Delhi: Approving for the amendment in warning statement for GSK Pharmaceuticals' Mepolizumab 100 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the warning statement as "To be used on prescription of Registered Medical Specialists experienced in treating the diseases for which drug is approved".This came after...
New Delhi: Approving for the amendment in warning statement for GSK Pharmaceuticals' Mepolizumab 100 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the warning statement as "To be used on prescription of Registered Medical Specialists experienced in treating the diseases for which drug is approved".
This came after the drug major, GSK Pharmaceuticals presented the proposal for amendment in the warning statement from "To be sold by retail on the prescription of a Registered Pulmonologist only" to "To be sold by retail on the prescription of a Registered Medical Specialists".
Mepolizumab is a fully-humanized monoclonal IgG1 kappa anti-IL-5 antibody used in conjunction with other therapies to treat severe asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. Mepolizumab binds with high affinity to IL-5, thus preventing its interaction with the IL-5 receptor expressed by eosinophils and, to a lesser extent, also by basophils
Earlier, the Medical Dialogue Teams reported that the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) approved the drug major GSK Pharma's proposal for amendment of protocol for conduct of Phase IV study of Mepolizumab Powder for Solution for Injection 100mg.
Now, in continuation, at the recent SEC meeting for Pulmonary held on November 4th 2022, the expert panel reviewed the proposal for amendment in the warning statement for GSK Pharmaceuticals' Mepolizumab 100 mg from "To be sold by retail on the prescription of a Registered Pulmonologist only" to "To be sold by retail on the prescription of a Registered Medical Specialists".
After detailed deliberation, the committee recommended for amendment in the warning statement as "To be used on the prescription of Registered Medical Specialists experienced in treating the diseases for which drug is approved".
In addition to this, the firm is also directed to submit the revised label and package insert to CDSCO.
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