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 17h 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 tuberculosis, Mycobacterium avium-intracellulare infection, and HIV-related opportunistic infections. It works by inhibiting mycobacterial cell metabolism and arresting multiplication through interference with metabolite synthesis. The drug is typically used in combination therapy to reduce resistance emergence.
$0.01BPart D
LOE ApproachingDeclining
As a legacy product approaching loss of exclusivity with minimal Part D spending ($10K in 2023), the commercial team is likely small and focused on maintaining market position in a contracted indication portfolio.
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.