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After consideration of these public comments, we are finalizing the aggregated data feedback provision in 512.760(d) as proposed

Cyanocobalamin is used for prophylaxis and treatment of cyanocobalamin deficiency caused by anaemia

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Bacteriostatic water and other bacteriostatic solutions are widely used in research and clinical settings, but the 0.9% benzyl alcohol component is contraindicated for neonates and may cause adverse effects in very young infants and certain sensitive populations