CDSCO panel agrees with Sun Pharmaceutical’s Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets

This came after the drug major Sun Pharmaceuticals presented a Phase IV clinical trial report of the fixed-dose combination (FDC) antimicrobial drug Cephalexin extended released (ER) 375mg/750mg plus Clavulanate Potassium 125mg/125mg tablets before the committee.

Phase IV clinical trial is a type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market.

Cephalexin is the first of the first-generation cephalosporins. This antibiotic contains a beta-lactam and a dihydrothiazide. Cephalexin is used to treat a number of susceptible bacterial infections through inhibition of cell wall synthesis. Cephalexin was approved by the FDA on 4 January 1971.

Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria. These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infection

Clavulanic acid is a beta-lactamase inhibitor used to enhance the effectiveness of beta-lactam antibiotics. Clavulanic acid is derived from the organism Streptomyces clavuligerus.

Clavulanic acid contains a beta-lactam ring in its structure that binds in an irreversible fashion to beta-lactamases, preventing them from inactivating certain beta-lactam antibiotics, with efficacy in treating susceptible gram-positive and gram-negative infections.

At the recent SEC meeting for antimicrobial and antiviral held on 9th May 2024, the expert panel reviewed the Phase IV clinical trial of the FDC antimicrobial drug Cephalexin extended released (ER) 375mg/750mg plus Clavulanate Potassium 125mg/125mg tablets.

After detailed deliberation, the committee noted and agreed to the result of the clinical trial report.

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