NDAORALFOR SUSPENSIONPriority Review
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
ZYVOX (linezolid) by Pfizer is 12. First approved in 2000.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYVOX (linezolid) is an oxazolidinone antibacterial agent that inhibits bacterial protein synthesis, approved in 2000 for serious infections caused by gram-positive bacteria including resistant strains. It is available in oral and intravenous formulations with 100% oral bioavailability, allowing flexible dosing without adjustment between routes. The drug treats hospitalized and community patients with infections such as pneumonia, skin infections, and bloodstream infections resistant to other antibiotics.
LOE Approaching
With LOE approaching, the brand team is likely in transition planning mode, with focus shifting toward lifecycle management and generic defense strategies rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Linezolid is an antibacterial drug [ see ] . 12.2 Pharmacodynamics In a randomized, positive- and placebo-controlled crossover thorough QT study, 40 healthy subjects were administered a single linezolid 600 mg dose via a 1 hour intravenous infusion, a single linezolid 1,200…
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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.