Pfizer's Novel Antibiotic Zavicefta (Ceftazidime-Avibactam) Receives NMPA Approval for Full Pediatric Indications in China

On May 8, Pfizer announced a new type of antibacterial drugZavicefta(Ceftazidime Avibactam Sodium for Injection)Recently received approval from China's NMPA for the treatment ofChildren of all ages(including newborns)Complicated Intra-abdominal Infections in Humans Caused by Gram-negative Bacteria（cIAI）、Hospital-acquired pneumonia and ventilator-associated pneumonia（HAP/VAP）, Infections with Limited Treatment Options。

Screenshot source: Pfizer Official Weibo

This approval is based on multiple clinical studies covering children of different age groups, which have demonstrated that Zavicefta has sufficient and effective clinical data for the pediatric population. The drug's instructions clearly specify dosage by age group.

Following this approval, Zavicefta (思福妥) can be used to treat adult and pediatric patients from birth with complicated intra-abdominal infections, hospital-acquired pneumonia, and ventilator-associated pneumonia caused by Gram-negative bacteria, as well as infections with limited treatment options.

Zavicefta is a compound antibacterial drug composed of ceftazidime and avibactam in a fixed ratio., can treat drug-resistant Gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae.（CRE）, Multidrug-Resistant Pseudomonas Aeruginosa (CRPA)、Production of extended-spectrum β-lactamases (ESBLs) Infections caused by bacteria, etc.

In May 2019, Zavicefta was approved by the NMPA for the first time, applicable for treating complicated intra-abdominal infections in adults and hospital-acquired pneumonia in adults. (HAP) Ventilator-associated pneumonia（VAP）、For the treatment of infections caused by Gram-negative bacteria sensitive to this product in adult patients with limited treatment options.

In September 2022, Zavicefta (Ceftazidime-Avibactam) received NMPA approval for the new indication to treat pediatric patients aged 3 months and above with complicated intra-abdominal infections.

In April 2025, Zavicefta was again approved by the NMPA for:

1）Complicated Intra-abdominal Infections（cIAI）

For use in combination with metronidazole for the treatment of adult and pediatric patients from birth who are infected with the following:Zavicefta-sensitive complicated intra-abdominal infections caused by Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, and Pseudomonas aeruginosa.

2）Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia（HAP/VAP）

Indicated for the treatment of adult and pediatric patients from birth with the following conditions:Zavicefta-sensitive Gram-negative bacteria causing hospital-acquired pneumonia and ventilator-associated pneumonia: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

3）In adult and pediatric patients from birth with limited treatment options,Treatment for the following pairsZefufu SensitivityInfections caused by Gram-negative bacteria: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa.