NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1971
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 4h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FREAMINE 8.5% is an intravenous amino acid injection indicated for muscle atrophy and pressure ulcer treatment in patients requiring parenteral nutrition support. This legacy product provides essential amino acids to promote protein synthesis and tissue repair in hospitalized and critically ill populations.
LOE Approaching
As a legacy injectable approaching LOE with limited patent protection, this product is experiencing consolidation pressure; commercial teams are typically focused on market defense and cost management rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
Started Jul 2025
100 enrolled
ESRD (End-Stage Renal Disease)Dialysis
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Started Jun 2024
55 enrolled
Hepatic SteatosisNAFLDAdolescent Obesity
The Glucagonotropic Effect of Amino Acids in Humans
Started Sep 2023
12 enrolled
Healthy
Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)
Started Sep 2023
10 enrolled
Phenylketonurias
Bioavailability of Plant Protein Amino Acids
Started Jan 2020
10 enrolled
Bioavailability of Amino Acids Following Oral Ingestion of Plant-Based Proteins in Young, Healthy Men
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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.