Aurobindo Pharma gets final approval for Amoxicillin for Oral Suspension
From USFDA
Aurobindo Pharma announced that the company 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 (ANDA 204030).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 talactamase-negative strains of the designated microorganisms.
The product has a market size of approximately US$ 19 Million for the twelve months ending July 2014 according to IMS.
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