NDAORALCAPSULEPriority Review
Approved
Dec 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
DROXIA (hydroxyurea) by Viatris (2) is known. Approved for polycythemia vera, sickle cell disease, essential thrombocythemia and 1 more indications. First approved in 1967.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DROXIA (hydroxyurea) is an oral antimetabolite approved in 1967 that inhibits DNA synthesis via ribonucleotide reductase inhibition. It treats 14 indications including sickle cell disease, myelodysplastic syndrome, leukemias, and solid tumors by increasing fetal hemoglobin, decreasing neutrophils, and improving red blood cell deformability.
$0.113MPart D
LOE ApproachingMature product in decline with limited growth opportunities; small dedicated team focused on retention and managed care contracting.
Mechanism of Action
known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. The mechanisms by which DROXIA produces its beneficial…
Pharmacologic Class:
Antimetabolite
Indications (4)
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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.