Hetero Labs Gets CDSCO Panel Nod To Study Antibiotic Tebipenem Pivoxil Dispersible Tablet
New Delhi: Stating that the decision to waive off the clinical trial will be taken after a review of the Bioequivalence study report, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the drug major Hetero Labs to conduct the bioequivalence (BE) study of the Tebipenem Pivoxil Dispersible tablets 50mg.
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.
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