Submit Clinical Comparative Data: CDSCO panel tells Abbott Healthcare On Metronidazole ER Tablet
New Delhi: Citing that the drug major Abbott Healthcare did not present any comparative clinical data of proposed drug product, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to submit comparative clinical data of proposed drug product i.e. Metronidazole Extended Release Tablets 600mg (Proposed dose: 2 x 600mg OD) with Metronidazole conventional Tablets 400mg (TS) with respect to proposed additional indication.
This came after the firm presented the proposal for the manufacture and marketing of Metronidazole Extended-Release Tablets 600mg for a proposed additional indication along with additional clinical and published data in support of additional indication before the committee.
Metronidazole is a nitroimidazole used to treat trichomoniasis, amebiasis, inflammatory lesions of rosacea, and bacterial infections, as well as prevent postoperative infections.
Metronidazole diffuses into the organism, inhibits protein synthesis by interacting with DNA, and causes a loss of helical DNA structure and strand breakage. Therefore, it causes cell death in susceptible organisms.
Metronidazole is FDA-approved for treating protozoal infections such as Trichomoniasis vaginalis, Entamoeba histolytica, Giardia lamblia, blastocysts, and Balantidium coli. It is also FDA approved to treat anaerobic bacterial infections caused by Bacteroides species, Fusobacterium species, Clostridium species, Gardnerella vaginalis, Helicobacter pylori, Prevotella species, Porphyromonas species, and Biophilia Wadsworth.
