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FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes

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It plays a vital role in the healthy functioning of many systems in the body, including the following: DNA (genetic material) synthesis Energy production (metabolism) Nerve cell health Neurological (brain) function Red blood cell (hemoglobin) formation Vitamin B12 plays a key role in the normal functioning of the brain and nervous system