Abbott Gets CDSCO Panel Nod To Manufacture, Market Clarithromycin ER Tablets 1000 mg
New Delhi: Pharmaceutical major Abbott has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market clarithromycin extended-release (ER) tablets 1000 mg.
However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial.
This came after the drug maker Abbott presented the justification for the Phase III clinical trial waiver along with the bioequivalence (BE) data 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 infections.
Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates 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 antimicrobials and antivirals held on October 24, 2024, the expert panel reviewed the justification for the Phase III clinical trial waiver along with BE data presented by drug maker Abbott.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Clarithromycin extended-release tablets, 1000 mg, subject to the condition that the firm shall conduct a Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol within 3 months from the date of approval to CDSCO for further review by the committee.
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