Aurobindo Pharma receives FDA approval for Isosulfan blue injection
05 February 2016 | News | By BioSpectrum Bureau
Aurobindo Pharma receives FDA approval for Isosulfan Blue injection
Isosulfan Blue Injection upon subcutaneous administration, delineates the lymphatic vessels
Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1 percent (50 mg/5 mL) single-dose vials. The product is expected to be launched in Q4 FY15-16.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) LymphazurinTM Injection, 1 percent, of Covidien. Isosulfan Blue Injection under Cardio Vascular therapeutic group, is used in a lymphography procedure.
Isosulfan Blue Injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. The approved product has an estimated market size of $57 million for the twelve months ending December 2015 according to IMS.
