NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
4/8 — Partial
Priority Review
NUZYRA (omadacycline) by Paratek Pharmaceuticals is 12. First approved in 2018.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUZYRA (omadacycline) is a novel tetracycline-class antibacterial agent approved in October 2018 for bacterial infections. It is a broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the ribosome. The drug is available in both oral tablet and intravenous formulations.
Peak11.4 years to LOE
Product is at peak lifecycle stage with stable commercial positioning; brand team size likely mature but not expanding significantly.
Mechanism of Action
12.1 Mechanism of Action NUZYRA is an antibacterial drug [see ]. 12.2 Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically…
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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.