Aurobindo Pharma obtains USFDA approval for Amoxicillin

Aurobindo Pharma Ltd received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Amoxicillin for oral suspension USP 125mg/5mL and 250mg/5mL.

This Abbreviated New Drug Application (ANDA) was approved out of unit XII, semi-synthetic Penicillin formulation facility in Hyderabad.

The drug is the generic equivalent to the reference listed drug product (RLD) Amoxicillin for oral suspension of Teva Pharmaceutical Industries Ltd and is indicated in the treatment of infections due to susceptible Beta lactamase-negative strains of the designated microorganisms.