NDAORALTABLETPriority 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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYVOX (linezolid) is an oxazolidinone antibiotic approved in 2000 that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It is used to treat serious gram-positive infections, including vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). The drug is available in both oral and intravenous formulations with approximately 100% bioavailability, allowing seamless IV-to-oral transition.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting transition from growth-focused to defensive strategy and reduced team expansion.
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…
Worked on ZYVOX at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.