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Administrative Document(s) and Correspondence - Accessdata FDA

Administrative Document(s) and Correspondence - Accessdata FDA 2025

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The document pertains to the supplemental Biologics License Application (BLA) 125276/S049 for Actemra (tocilizumab), submitted by Hoffman-La Roche. It includes administrative details, pediatric considerations, and labeling recommendations related to the drug's use in adults with rheumatoid arthritis and systemic juvenile idiopathic arthritis. The document outlines the regulatory process, including responses to Pediatric Research Equity Act (PREA) requirements, waivers for pediatric studies, and correspondence regarding labeling revisions and safety monitoring for hypersensitivity reactions.

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Click ‘Get Form’ to open it in the editor.
Begin by entering the Application Number at the top of the form. This is crucial for tracking your submission.
Fill in the Proprietary Name and Established/Generic Name fields with accurate information about the drug.
Complete the Dosage Form section, specifying how the drug will be administered (e.g., Injection, for intravenous infusion).
Address all indication questions thoroughly, ensuring that each pediatric subpopulation is considered as required.
For questions regarding PREA PMR responses, select 'Yes' or 'No' as applicable and provide any necessary details.
Review all sections carefully before submitting to ensure completeness and accuracy. Attach any additional documents if required.

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Administrative Document(s) and Correspondence - Accessdata FDA 2025

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