Prescription medicine
Avibactam and aztreonam Brand names: Emblaveo
Avibactam and aztreonam (Emblaveo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the avibactam and aztreonam FDA label on DailyMed (effective June 24, 2026, AbbVie Inc.); the NDA 217906 record on Drugs@FDA; every avibactam and aztreonam label on DailyMed.
Highlights of the record
FDA label of June 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebs
Forms and strengths
- 127 mg/ml / 42.3 mg/ml
Powder for solution.
On the market
- Earliest approval on file
- February 7, 2025 Emblaveo, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 15, 2032 Emblaveo injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1 through July 30, 2026
What is avibactam and aztreonam used for?
From the label: indications and usageEMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. […]
FDA pharmacologic class: Monobactam Antibacterial and beta Lactamase Inhibitor.
Source: FDA drug label (EMBLAVEO), AbbVie Inc., effective June 24, 2026 (SPL set be1a6c99-d4b3-46d7-9e99-6e5f9fab556a), via openFDA; the full label on DailyMed
Is there a generic for avibactam and aztreonam (Emblaveo)?
No generic avibactam and aztreonam is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Emblaveo injection: the compound patent runs to June 15, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the avibactam and aztreonam label say about other medicines?
The avibactam and aztreonam label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Probenecid | drug interactions | DRUG INTERACTIONS 7.1 OAT 1 and 3 Transport Inhibitors Concomitant use of organic anion transporter (OAT) 1 and OAT 3 transporter inhibitors (e.g., probenecid) with EMBLAVEO is not recommended. |
Source: FDA drug label (EMBLAVEO), AbbVie Inc., effective June 24, 2026 (SPL set be1a6c99-d4b3-46d7-9e99-6e5f9fab556a), via openFDA; the full label on DailyMed
What do FAERS reports show for avibactam and aztreonam?
The FDA Adverse Event Reporting System holds 1 report that list avibactam and aztreonam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other monobactam antibacterials
- the pharmacologic class, with prices and generics
- Avibactam and aztreonam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other