Lupin gets CDSCO committee approval for marketing Ranibizumab
New Delhi: In a major rejoice to drug maker Lupin, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod for marketing Ranibizumab, which is used to treat certain serious eye conditions such as age-related macular degeneration, macular edema, diabetic retinopathy. However, the SEC approval came with certain conditions.
This came in wake of the proposal presented by pharmaceutical major, Lupin for marketing authorization based on the results of Phase III multicentre clinical trial conducted in the country.
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use and it is used in the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
It acts by binding to human vascular endothelial growth factor A resulting in suppression of the biologic activity of human vascular endothelial growth factor A (VEGF-A).
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