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Nouress FDA Approval History

Last updated by Judith Stewart, BPharm on April 25, 2020.

FDA Approved: Yes (First approved December 13, 2019)
Brand name: Nouress
Generic name: cysteine hydrochloride
Dosage form: Injection
Company: Avadel Pharmaceuticals plc
Treatment for: Total Parenteral Nutrition

Nouress (cysteine hydrochloride) is a sulfur-containing amino acid indicated for use as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition.

Development Timeline for Nouress

DateArticle
Dec 16, 2019Approval  FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)
Aug  8, 2019Avadel Pharmaceuticals Receives New PDUFA Date for AV001 of December 15, 2019
May 22, 2019Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for AV001

Further information

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