Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Amoxicillin for oral suspension.
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 Betalactamase-negative strains of the designated microorganisms.
The product had a market size of approximately $19 million for the 12 months ending July 2014, according to IMS.
"This Abbreviated New Drug Application (ANDA) was approved out of Unit XII, Semi-Synthetic Penicillin formulation facility here,” the Hyderabad-based company said in a release issued here on Tuesday.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.