NDAORALTABLETPriority Review
Approved
Nov 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
MYAMBUTOL (ethambutol hydrochloride) by Bayer is clinical pharmacology ethambutol hcl, following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 mcg/ml in serum 2 to 4 hours after administration. Approved for pulmonary tuberculosis. First approved in 1967.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Myambutol (ethambutol hydrochloride) is an oral small-molecule antimycobacterial agent approved in 1967 for treatment of pulmonary tuberculosis. It works by inhibiting mycobacterial metabolite synthesis, impairing cell metabolism and arresting multiplication of Mycobacterium tuberculosis. The drug is typically used as part of multi-drug combination therapy to prevent resistance.
$0.01BPart D
LOE ApproachingProduct is in late-stage lifecycle with minimal Medicare Part D volume, indicating a small, mature commercial team focused on maintenance rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY ETHAMBUTOL HCL, following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 mcg/mL in serum 2 to 4 hours after administration. When the drug is administered daily for longer periods of time at this dose, serum levels are similar. The serum level of…
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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.