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news.The US Food & Drug Administration (USFDA) has issued final approval to produce and market Aurobindo Pharma’s generic version of Amoxicillin for oral suspension to treat infections in the American market.
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Amoxicillin for oral suspension USP 125mg/5mL and 250mg/5mL is the standard equivalent to the Teva Pharmaceutical Industries’ reference listed drug product (RLD), Amoxicillin for oral suspension.
This drug can be used to treat infections cropping up to due to susceptible aetalactamase-negative strains of the designated microorganisms.
Aurobindo said in a statement: "This Abbreviated New Drug Application (ANDA) has been approved out of Unit XII, Semi-Synthetic Penicillin (SSP) formulation facility in Hyderabad, India."
According to sales data from IMS, Amoxicillin captures a market size of about $19m for the year ending July 2014.
Further, the Indian Pharmaceutical firm currently has 195 ANDA approvals from the USFDA.