NDAORALCAPSULEPriority Review
Approved
Jul 1969
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
MATULANE (procarbazine hydrochloride) by Leadiant Biosciences is clinical pharmacology the precise mode of cytotoxic action of procarbazine has not been clearly defined. First approved in 1969.
Drug data last refreshed 22h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MATULANE (procarbazine hydrochloride) is an oral alkylating agent approved in 1969 for hematologic malignancies, particularly Hodgkin lymphoma. The drug works through multiple mechanisms including inhibition of protein, RNA, and DNA synthesis, with evidence suggesting it may disrupt t-RNA function and directly damage DNA through hydrogen peroxide generation. It is rapidly absorbed orally and crosses the blood-brain barrier, making it suitable for CNS-penetrant therapy.
$0.002BPart D
LOE ApproachingStable
This legacy product shows modest Part D utilization with a small, specialized patient population; commercial teams are likely consolidating resources as loss of exclusivity approaches.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mode of cytotoxic action of procarbazine has not been clearly defined. There is evidence that the drug may act by inhibition of protein, RNA and DNA synthesis. Studies have suggested that procarbazine may inhibit transmethylation of methyl groups of methionine into…
Indications
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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.