Aurobindo Pharma receives USFDA approval for Amoxicillin for Oral Suspension

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

Amoxicillin for Oral Suspension USP 125mg/5mL and 250mg/5mL is the generic equivalent to the reference listed drug product (RLD), Amoxicillin for Oral Suspension, 125mg/5 mL and 250mg/5mL respectively of Teva Pharmaceutical Industries and indicated in the treatment of infections due to susceptible βetalactamase-negative strains of the designated microorganisms.

According to IMS, the product has a market size of approximately $19 million for the twelve months ending July 2014. These ANDAs has been approved out of Unit XII, Semi-Synthetic Penicillin (SSP) formulation facility in Hyderabad, India.

Aurobindo now has a total of 195 ANDA approvals (169 Final approvals including 7 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.