NDAINTRAVENOUSPOWDERPriority 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 48m ago · AI intelligence enriched 22h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUZYRA (omadacycline) is a tetracycline-class antibacterial administered intravenously as a lyophilized powder. It inhibits bacterial protein synthesis through ribosomal binding, providing broad-spectrum activity against both gram-positive and gram-negative organisms. The drug targets patients requiring IV antibiotic therapy for serious infections where oral alternatives are insufficient.
Peak11.1 years to LOE
Product is at peak commercial maturity with active regional and specialty sales roles, indicating stable team investment across commercial and QA functions.
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.