NDAORALSOLUTIONPriority Review
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
XROMI (hydroxyurea) by Teva is cannot, at present, be described. Approved for polycythemia vera, sickle cell disease, essential thrombocythemia. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XROMI is an oral solution formulation of hydroxyurea, an antimetabolite that inhibits DNA synthesis by acting as a ribonucleotide reductase inhibitor. It is indicated for polycythemia vera, sickle cell disease, and essential thrombocythemia. The drug works by blocking DNA synthesis in cancer and disease-causing cells while leaving RNA and protein synthesis intact.
Growth15.6 years to LOE
Recent 2024 approval positions XROMI in early growth phase with potential for market expansion as a convenient oral formulation in a competitive myeloproliferative disorder landscape.
Mechanism of Action
cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of…
Pharmacologic Class:
Antimetabolite
Indications (3)
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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.