Dec. 16, 2019: Avadel Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved NouressTM (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition (TPN).
Additionally, Avadel announced that the United States Patent and Trademark Office (USPTO) recently issued the United States Patent No. 10,493,051 covering cysteine solutions that includes the approved Nouress product (listed in the Orange Book for Nouress) and is set to expire in March of 2039.
This validates our strategy for developing innovative medicines for the patients. Nouress is the fourth FDA approved product in the sterile injectable hospital business. https://fda.einnews.com/pr_news/504993767/avadel-pharmaceuticals-receives-u-s-fda-approval-for-nouress-av001-a-cysteine-hydrochloride-injection-for-treating-neonate-patients-requiring
