Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue injection.
The approved Abbreviated New Drug Application is bioequivalent and therapeutically equivalent to the reference listed drug product, Lymphazurin injection, of Covidien. It is used in the lymphography procedure in cardio-vascular therapeutics.
The product has an estimated market size of $57 million for the 12 months ending December 2015, according to IMS.
Aurobindo’s scrip gained 0.78 per cent on the Bombay Stock Exchange on Wednesday and was trading at Rs 772.50 at noon.