CDSCO Panel Rejects Abbott Healthcare's Proposal To Waive Local CT of Clarithromycin ER Tablets
New Delhi: Rejecting the drug major Abbott Healthcare's request for a local clinical trial waiver of Clarithromycin extended-release (ER) tablets 1000mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct the bioequivalence (BE) study and Phase III clinical trial (CT) of Clarithromycin ER Tablets 1000mg.
This came after the drug major Abbott Healthcare presented the proposal for a grant of permission to manufacture and marketing of Clarithromycin ER Tablets 1000mg, along with the report for a local clinical trial waiver before the committee.
Clarithromycin is a macrolide antibiotic used for the treatment of a wide variety of bacterial infections such as acute otitis, pharyngitis, tonsillitis, respiratory tract infections, uncomplicated skin infections, and helicobacter pylori infection.
Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates the bacteria cell walls and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis.
Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.
At the recent SEC meeting for Antimicrobial and Antiviral held on 31st May 2022, the expert panel reviewed the proposal presented by drug major Abbott Healthcare for the grant of permission to manufacture and marketing of Clarithromycin ER Tablets 1000mg, along with the report for a local clinical trial waiver.
The committee observed that the justification presented by the firm is inadequate.
After detailed deliberation, the committee did not consider for clinical trial waiver and recommended that the firm should conduct BE study along with Phase III clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase III CT protocol for further review by the committee.
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