CDSCO Panel opins Abbott Healthcare to Conduct Phase III CT of Clarithromycin ER Tablets 1000mg

The committee noted that proposed drug, Clarithromycin ER tablet 1000mg is presently not approved anywhere in the world.

"Clarithromycin ER tablet 1000mg had been approved in the year 2005. However, later on the same was withdrawn from the US market due to unknown reasons." the expert panel noted.

Furthermore, the committee stated that there is no specific unmet medical need of proposed formulation.

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, a semisynthetic macrolide antibiotic derived from erythromycin, inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the translation and protein assembly process. Clarithromycin may be bacteriostatic or bactericidal depending on the organism and drug concentration.

At the recent SEC meeting for antimicrobial and antiviral held on 9th May 2024, the expert panel reviewed the BE report along with justification for waiver of Phase-III clinical trial of the antimicrobial drug Clarithromycin ER Tablets.

After detailed deliberation, the committee reiterated its earlier SEC recommendation to conduct a Phase-III clinical trial.

Accordingly, the expert panel suggested that the firm should submit Phase-III clinical trial protocol to CDSCO for further review by the committee.

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