NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
NOURESS (cysteine hydrochloride) by Baxter is enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. First approved in 2019.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOURESS (cysteine hydrochloride) is an intravenous amino acid supplement for neonates requiring parenteral nutrition who cannot synthesize adequate cysteine due to cystathionase deficiency. It functions as a precursor substrate for glutathione and taurine synthesis via the trans-sulfuration pathway. This is a critical micronutrient product addressing a rare metabolic gap in neonatal intensive care.
Peak12.9 years to LOE
Product is in peak commercial stage with established market position; niche indication supports stable, specialized sales and medical affairs infrastructure.
Mechanism of Action
enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. Cysteine hydrochloride injection, USP provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
NOURESS positions professionals in the specialized neonatal care and parenteral nutrition segment, a stable but niche market with limited competitive noise and strong relationships with NICU pharmacy and clinical leadership. Roles on this product emphasize deep clinical credibility, institutional relationships, and expertise in metabolic nutrition—ideal for specialists seeking stability over high-growth trajectory.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.