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Following the end of that development program, AOD9604 received a GRAS (Generally Recognized As Safe) designation from the FDA for use as a food ingredient a regulatory category that is separate from, and does not equate to, approval as a pharmaceutical drug
The average infant blood vitamin B 12 level at 8 weeks postpartum was 506 pmol/L (686 ng/L).[28] Three hundred fifty-three infants born to women in Bangladesh taking a daily multinutrient supplement containing 2.6 mcg vitamin B 12 from the first trimester of pregnancy through 3 months postpartum had a median blood vitamin B 12 level at 6 months postpartum of 221 pmol/L (299 ng/L)
