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In response to additional comments, we explain more about our evaluation of the evidence submitted for both applications

They are classified as bulk drug substances and are available only through a licensed prescribing provider and compounding pharmacy

The goal is not short-term relief

Options for vitamin B12 treatment include: Depending on the cause of the deficiency, you may only need treatment until your vitamin B12 levels are back to normal, or you may need B12 therapy for the rest of your life