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Avadel's injection for neonatal nutrition approved by US FDA


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Avadel's injection for neonatal nutrition approved by US FDA

Avadel Pharmaceuticals PLC's Nouress, an injection that provides nutrition to neonatal patients, has been approved by the U.S. Food and Drug Administration.

Nouress is a cysteine hydrochloride injection for neonatal patients that require total parenteral nutrition, a feeding system that delivers liquid nutrients like carbohydrates, proteins and fats intravenously, according to the Mayo Clinic.

Dublin-based Avadel, a pharmaceutical company focused on treating narcolepsy, also said in a Dec. 16 press release that the U.S. Patent and Trademark Office has issued a patent covering the Nouress product. The patent is set to expire in March 2039. The company has other U.S. patent applications pending for Nouress.

Avadel said the U.S. launch date for Nouress is still being decided. A similar product manufactured by Exela Pharma Sciences LLC called ELCYS was approved by the FDA in May, with an immediate launch.

Shares of Avadel were down 12.22% to $6.32 as of 12:07 p.m. ET on Dec. 16.