United States-based pharmaceutical company AbbVie (NYSE: ABBV announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for its EMBLAVEO (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/beta-lactamase inhibitor combination antibiotic.
AbbVie said that EMBLAVEO is approved in combination with metronidazole, for 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.
EMBLAVEO is approved for this indication based on limited clinical safety and efficacy data. It will be available for commercial use in the United States during the third quarter of 2025.
Eneboparatide Shows Positive Results in Phase III Trial for Chronic Hypoparathyroidism
Precision BioSciences secures IND clearance for gene editing therapy targeting chronic hepatitis B
Xeris Biopharma secures FDA approval for Gvoke VialDx as diagnostic aid
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer
ANI Pharmaceuticals secures FDA approval for ILUVIEN label expansion
Korro Bio receives FDA orphan drug designation for KRRO-110
SpliceBio doses first patient in Phase 1/2 ASTRA study of SB-007
Amgen reports positive Phase 3 trial results for UPLIZNA in generalised myasthenia gravis
Femasys receives CE mark approval for FemBloc delivery system in Europe
European Commission approves Rxulti for adolescent schizophrenia treatment
Celltrion launches STELARA biosimilar STEQEYMA in US market
Hansa Biopharma completes enrolment for 20-HMedIdeS-19 PAES study
FDA accepts BLA filing for NS Pharma's deramiocel
Celltrion's OMLYCLO receives US FDA approval
RiboX Therapeutics doses first patient in RXRG001 first-in-human Phase I/IIa clinical trial