AMINOSYN-PF 7%
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
Sep 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AMINOSYN-PF 7% (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 7% 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 4 more indications. First approved in 1985.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN-PF 7% is a pediatric-specific amino acid injection formulated to provide essential and nonessential amino acids plus taurine for total parenteral nutrition (TPN) support in infants and young children. It is designed to approximate the plasma amino acid profile of breast-fed infants when combined with cysteine hydrochloride additive. The product treats negative nitrogen balance and protein malnutrition in pediatric patients unable to receive adequate nutrition through oral or gastrointestinal routes.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30%), suggesting consolidating team size and focus on margin preservation rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Aminosyn-PF 7% 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.