This came after the firm presented the proposal for a grant of permission to conduct a bioequivalence study and justification for Phase III clinical trial waiver with the drug Tebipenem Pivoxil Dispersible tablets 50mg.
Tebipenem Pivoxil is an orally available pivaloyloxymethyl ester prodrug of tebipenem, a broad-spectrum 1-beta-methylcarbapenem antibiotic with a 1-(1,3-thiazolin-2-yl) azetidin-3-ylthio group at the C-2 position. After oral administration of tebipenem pivoxil, the ester bond is cleaved, releasing active tebipenem.
Tebipenem is a broad-spectrum orally-administered antibiotic, from the carbapenem subgroup of β-lactam antibiotics. It was developed as a replacement drug to combat bacteria that had acquired antibiotic resistance to commonly used antibiotics. Tebipenem is formulated as the ester tebipenem pivoxil due to the better absorption and improved bioavailability of this form.
Tebipenem acts by binding to penicillin-binding proteins, inhibiting the synthesis of the bacterial cell wall. This results in the weakening of peptidoglycan, leading to lysis of bacterial cells
At the recent SEC meeting for Antimicrobial and Antiviral held on 28th June 2023, the expert panel reviewed the proposal presented by Hetero Labs for a grant of permission to conduct a bioequivalence study and justification for Phase III clinical trial waiver with the drug Tebipenem Pivoxil Dispersible tablets 50mg.
After detailed deliberation, the committee recommended that the firm may conduct BE study as per the protocol presented and submit the BE study results.
Furthermore, the expert panel added that the decision to waive the clinical trial will be taken after a review of Bioequivalence the study report, subject to regulatory compliance as per CDSCO guidelines.
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