Aurobindo gets USFDA approval for anti-infection drug

The ANDA was approved out of unit 12, semi-synthetic Penicillin facility in Hyderabad

Hyderabad-based Aurobindo Pharma Limited today announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and makret Amoxicilin for oral suspension.

This Abbreviated New Drug Application (ANDA) was approved out of unit 12, semi-synthetic Penicillin facility in Hyderabad, the company said in a press release. The product has a market size of $ 19 million for the twelve month period ending July 2014, it said quoting the IMS data.

This oral suspension is a generic equivalent to the reference listed drug product of Teva Pharmaceutical Industries Limited and indicated in the treatment of certain bacterial infections., according to the release.