NDAORALSOLUTIONPriority Review
Approved
Jun 1964
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Data completeness
3/8 — Basic
Priority Review
AMICAR (aminocaproic acid) by Hikma. Approved for antifibrinolytic agent [epc]. First approved in 1964.
Drug data last refreshed 18h ago · AI intelligence enriched 21h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMICAR (aminocaproic acid) is an oral antifibrinolytic agent approved in 1964 that works by inhibiting plasminogen activation to reduce excessive bleeding. It is used to treat or prevent excessive bleeding in patients with fibrinolytic disorders or those undergoing procedures with high bleeding risk.
LOE Approaching
Established legacy product with LOE approaching suggests a small, maintenance-focused team managing brand extension and generic transition strategies.
Mechanism of Action
Pharmacologic Class:
Antifibrinolytic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on AMICAR offers exposure to legacy product management, generic transition strategy, and niche hemostasis markets; career value lies in learning how to maintain profitability and market access in LOE environments. This role is best suited for professionals seeking hands-on brand stewardship and healthcare policy experience rather than breakthrough innovation.
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.