Submit in vitro study data and justify dose: CDSCO Panel Tells Akums Drugs on Veterinary Antibiotic FDC
New Delhi: Responding to the proposal presented by Akums Drugs and Pharmaceutical regarding the veterinary antibiotic combination amoxycillin 3 gm plus clavulanic acid 600 mg, the Subject Expert Committee (SEC), functional under the Central Drug Standard Control Organization (CDSCO), has recommended the firm to submit and present the in vitro study data on efficacy, susceptibility, and justification for dose selection in target animals, maximum dose, schedule of dosing, and withdrawal period.
This came after Akum Pharmaceutical presented the proposal before the SEC committee.
Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Amoxicillin is a penicillin antibiotic. It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers.
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