Pfizer gets CDSCO Panel nod to import, market antimicrobial FDC for additional Indication

Written by Dr. Divya Colin Published On 2022-10-10T18:00:03+05:30 | Updated On 10 Oct 2022 6:00 PM IST

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.

However, the nod is subjected to condition that the firm should conduct the Phase IV clinical study (CT) study and the protocol should be presented before the committee for review.

This came after the firm presented their proposal along with justification, in light of earlier recommendation dated 26.07.2022.

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.

Earlier, at 116th SEC meeting for Antimicrobial & Antiviral held on 26.07.2022, in response to drug major Pfizer proposal for import and marketing of above said approved FDC in additional indication, the expert panel opined that the firm should submit the justification along with efficacy & safety data on Indian patients for proposed indication before the committee for further review.

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

In addition, the firm informed the committee that the product is already approved in EU countries.

After detailed deliberation, the committee recommended the grant of permission for import and marketing of the proposed additional indication with condition to conduct the Phase IV CT study.

Furthermore, the committee directed that the protocol should be presented before the committee for review.

Also Read: Zydus Healthcare gets CDSCO panel nod to manufacture, market Indacaterol, Budesonide Inhaler

pfizerAvibactam SodiumCeftazidimeantimicrobialfdccdscosec committee

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.