CDSCO panel tells Abbott to present more data on Metronidazole Extended Release Tablet
New Delhi: Denying the pharmaceutical major Abbott Healthcare proposal to manufacture and market antibiotic Metronidazole Extended Release Tablet for the additional indication, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended the firm to present additional clinical and published data in support of the proposed additional indication.
This came during the SEC meeting for Dentistry held on 25th May 2022, where the proposal presented by pharma major Abbott Healthcare to manufacture and market antibiotic Metronidazole Extended Release Tablet 600mg for the additional indication was discussed.
Metronidazole is a medicine used to treat different types of bacterial and parasitic infections, including those that affect the skin, vagina, blood, heart, bone, stomach, liver, joints, nervous system, respiratory tract, and other areas of the body.
This medicine is also prescribed to treat sexually transmitted diseases (STDs). The extended-release form of metronidazole is used to treat bacterial vaginosis (an infection caused by too much harmful bacteria in the vagina) in women.
Metronidazole is in a class of drugs called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
This medicine will only help infections caused by bacteria and will not work for the common cold, flu, or other viral infections.
At the recent SEC meeting for Dentistry held on 25th May 2022, the expert panel reviewed the proposal presented by pharma major Abbott Healthcare to manufacture and market antibiotic Metronidazole Extended Release Tablet 600mg for the proposed additional indication.
After detailed deliberation, the committee recommended that the firm should present additional clinical and published data in support of the proposed additional indication before the committee for further consideration.
