NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
NOURESS (cysteine hydrochloride) by Baxter International 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 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOURESS (cysteine hydrochloride) is an intravenous amino acid supplement indicated for neonates requiring parenteral nutrition who cannot synthesize adequate cysteine due to cystathionase deficiency. The drug acts as a precursor substrate for glutathione and taurine synthesis via the trans-sulfuration pathway, restoring essential metabolic function in critically ill newborns.
Peak12.4 years to LOE
Product is at peak lifecycle with established market position and likely stable team structure; limited growth trajectory may constrain headcount expansion.
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 is a niche hospital-based pediatric product with minimal linked job openings, reflecting its specialized market and small patient population. Career opportunities center on hospital formulary management, neonatal clinical support, and regulatory maintenance rather than high-growth commercial expansion.
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.