Aurobindo gets USFDA nod to market generic anti-infective drug

Aurobindo Pharma has received approval from the US health regulator to market generic version of Amoxicillin for oral suspension, used to treat infections, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Amoxicillin for Oral Suspension USP, the Hyderabad-based firm said in a statement.
Amoxicillin for Oral Suspension is the generic equivalent to the Teva Pharmaceutical Industries' product and indicated in the treatment of infections, it added.
According to IMS sales data, the product has a market size of around USD 19 million for the 12 months ended July 2014.

"This abbreviated new drug application (ANDA) has been approved out of Unit XII, semi-synthetic penicillin (SSP) formulation facility in Hyderabad," the company said.
Aurobindo now has a total of 195 ANDA approvals from the USFDA.
Shares of Aurobindo Pharma today closed at Rs 854.30 apiece on the BSE, down 4.25 per cent from the previous close.