CDSCO panel opines Sun Pharma to submit more safety data of Ranibizumab Solution for Injection
New Delhi: Responding to the proposal presented by the pharmaceutical major Sun Pharma for approval of additional indications for the already approved drug product of Ranibizumab solution for injection 10 mg/ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should submit more safety data for consideration of approval of the additional indications.
This came after the drug major Sun Pharma presented their proposal for approval of additional indications for the already approved drug product of Ranibizumab solution for injection 10 mg/ml.
Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). VEGF is a biochemical signal protein that promotes angiogenesis throughout the body and in the eye.
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