Justify Rationality of FDC Meropenem plus Sodium Carbonate plus Avibactam: CDSCO Panel Tells Akum Pharmaceutical

New Delhi: Reviewing the proposal presented by the drug major Akum Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the justification and rationality of the fixed-dose combination (FDC) antimicrobial drug Meropenem Trihydrate IP (Sterile) eq. to Anhydrous Meropenem 1000mg + Sodium Carbonate eq. to Sodium 90.2mg + Avibactam Sodium (Sterile) eq. to Avibactam 500mg injection.

This came after the firm presented the proposal before the committee regarding the fixed-dose combination (FDC) antimicrobial drug Meropenem Trihydrate IP (Sterile) eq. to Anhydrous Meropenem 1000mg + Sodium Carbonate eq. to Sodium 90.2mg + Avibactam Sodium (Sterile) eq. to Avibactam 500mg injection.

Meropenem is a carbapenem antibiotic used to treat a wide variety of infections in the body. Meropenem is a broad-spectrum carbapenem antibiotic.

Meropenem injection is used to treat infections caused by bacteria. It works by killing the bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections. This medicine is to be given only by or under the direct supervision of your doctor.

Avibactam is a non-β-lactam β-lactamase inhibitor used in combination with ceftazidime for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital or ventilator-acquired pneumonia.

Avibactam has an unusual mechanism of action: it is a covalent inhibitor that acts via ring opening, but in contrast to other currently used β-lactamase inhibitors, this reaction is reversible. Here, we present a high-resolution structure of avibactam bound to a class C β-lactamase, AmpC, from P.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the proposal for the FDC antimicrobial drug Meropenem Trihydrate plus Anhydrous Meropenem plus Sodium Carbonate plus Avibactam Sodium injection.

After detailed deliberation, the committee recommended the following:

1. The firm should present the justification on rationality for combining this FDC and its significant benefit along with recent supporting documents/ literature.

2. Justification on dose titration with recent supporting documents/ literature.

3. International approval status.

4. Recent scientific literature available from peer-reviewed journals in support of combining the proposed FDC.

Accordingly, the expert panel suggested that the firm should submit the above data for further review by the committee.

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