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It remains investigational and is still being studied in clinical trials, and it has not received FDA approval, so it is not yet available through a pharmacy or clinic outside of trial participation

This injection is typically prescribed to potentially prevent or treat deficiencies of these B vitamins and to support patients with conditions like malabsorption, increased metabolic demand, or recovery from illness where oral vitamin intake is insufficient

MECHANISM CATEGORIES SAFETY Side effects Generally well-tolerated in trials at the doses tested Injection-site reactions Known interactions Not characterized in Phase 3 Contraindications Pregnancy/lactation (unstudied) REGULATORY STATUS FDA Not FDA-approved as a drug

After Reconstitution: Store at 28C

Perry Genova, our senior vice president of research and development, and our engineering team for achieving this significant development milestone on an aggressive schedule during the fourth quarter of 2018