The Food and Drug Administration has approved Nouress (cysteine hydrochloride injection; Avadel) for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than 1 month of age) requiring total parenteral nutrition (TPN).

Nouress provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities of cysteine due to deficient cystathionase activity. The product is administered as an intravenous infusion and must be diluted and used as an admixture in parenteral nutrition solutions.

Nouress will be supplied as 500mg/10mL cysteine hydrochloride solution in single-dose vials. The product contains aluminum; when preterm and term neonates are administered the recommended maximum dosage, exposure to aluminum from Nouress is not more than 0.25mcg/kg/day. When prescribing Nouress for use in parenteral nutrition containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5mcg/kg/day. 

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In the US, supply issues leading to a critical shortage of cysteine hydrochloride injection prompted the FDA to allow the product to be imported from Canada. While Avadel has not yet determined when Nouress will launch in the US, the Company believes the availability of their product, in addition to the approval of another cysteine hydrochloride product earlier this year, should provide a sufficient domestic supply.

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