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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUZYRA (omadacycline) is a tetracycline-class antibacterial small molecule administered intravenously as a powder for injection. It inhibits bacterial protein synthesis and is indicated for serious bacterial infections where oral therapy is not feasible or appropriate. The drug demonstrates broad-spectrum coverage with a favorable pharmacokinetic profile including a 15–16 hour half-life and minimal protein binding (20%).
Peak11.4 years to LOE
Product is at peak lifecycle stage with 31 linked job openings, predominantly in specialty sales, indicating active commercialization and team expansion.
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.