Pfizer gets CDSCO Panel nod to import, market antimicrobial FDC for additional Indication
New Delhi: Pharmaceutical major Pfizer has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to import and market the fixed dose combination(FDC) drug containing Avibactam Sodium plus Ceftazidime Powder for concentrate for solution for infusion for additional indication.
Avibactam is a non-β-lactam β-lactamase inhibitor that has been approved in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and nosocomial pneumonia, including ventilator-associated pneumonia.
It inactivates some β-lactamases by a unique covalent and reversible mechanism, and protects ceftazidime from degradation by certain β-lactamases.
Avibactam rapidly reaches the periplasm of bacteria at high enough concentrations to restore activity of ceftazidime against ceftazidime-resistant, β-lactamase-producing strains.
Ceftazidime is broad-spectrum third-generation cephalosporin beta-lactam antibiotic used to treat or prevent a variety of bacterial infections, including pneumonia, gynecological infections, bone and joint infections, and septicemia, among others.
In Europe, ceftazidime-avibactam is also approved for the treatment of Gram-negative infections with limited treatment options.
At the recent SEC meeting for Antimicrobial & Antiviral held on September 27th 2022, the expert panel reviewed the proposal presented by the firm to import and market the FDC containing Avibactam Sodium plus Ceftazidime Powder along with the justification
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