 "Aurobindo gets USFDA final nod for Isosulfan Injection")
Aurobindo Pharma has said that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Isosulfan Blue Injection, 1% single-dose vials, used in a lymphography procedure.
The approved abbreviated new drug application(ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Lymphazurin of Covidien. The approved product has an estimated market size of $ 57 million for the twelve months ending December, 2015, according to IMS data.
The company on Tuesday had also announced the receipt of final approvals from the US FDA for Celecoxib capusules and Levetiracetam Injection, used for treating arthritis and treatment of partial onset seizures respectively.