CDSCO Panel Approves Updated Package Insert for Novartis' Ofatumumab Injection
New Delhi:The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the proposal presented by the drug major Novartis for update in package insert for the drug product Ofatumumab solution for injection in pre-filled syringe of 20 mg/0.4 mL with changes in sections of contraindications, warnings and precautions, patient counseling information and instructions for use
This came after the firm presented the proposal for an update in the package insert for the drug product Ofatumumab solution for injection in a pre-filled syringe of 20 mg/0.4 mL based on the U.S. pack insert dated 12 April 2024 with changes in Sections of Contraindications, Warning and Precaution, Patient Counseling Information, and Instructions for Use.
Ofatumumab, a fully human anti-CD20 monoclonal antibody, is a disease-modifying therapy (DMT) approved for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS in adults
At the recent SEC meeting for Neurology and Psychiatry, the expert panel reviewed the proposal presented by Novartis for an update in the package insert for the drug product Ofatumumab solution for injection in a pre-filled syringe of 20 mg/0.4 mL.
After detailed deliberation, the committee recommended the approval of the updated package insert dated 26 July 2024 of the drug product for the proposed changes.
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