Aurobindo Pharma has got the final approval of the US health regulator for manufacturing and marketing generic Isosulfan Blue injection in the American market.
Aurobindo Pharma said in a statement that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue injection 1 per cent (50 mg/5 mL) single-dose vials.
It further added that the product is likely to be launched in the fourth quarter of the current fiscal.
As per the statement “The approved product has an estimated market size of USD 57 million for the twelve months ending December 2015, according to IMS.”