AMINOSYN-PF 10%
LOE Approachingisoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine
NDAINJECTIONINJECTABLE
Approved
Oct 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AMINOSYN-PF 10% (isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine) by Otsuka is clinical pharmacology aminosyn-pf 10%, sulfite-free, (an amino acid injection — pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. Approved for nitrogen, weight loss, treat negative nitrogen balance in infants and 3 more indications. First approved in 1986.
Drug data last refreshed 2d ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN-PF 10% is a pediatric-formulated amino acid injection containing 18 essential and nonessential amino acids plus taurine, designed to provide parenteral nutritional support for infants and young children unable to receive adequate oral or enteral nutrition. It works by delivering a balanced amino acid profile that approximates breast-fed infant plasma concentrations, supporting nitrogen balance, weight gain, and protein synthesis in neonatal total parenteral nutrition (TPN).
LOE Approaching
Product approaching end-of-life with legacy market positioning; brand team likely focused on market maintenance and efficiency rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. The amino acid composition has been specifically formulated to provide a well-tolerated nitrogen source for nutritional…
Pharmacologic Class:
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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.