Aurobindo Pharma Ltd on Wednesday said that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1%, which is used in lymphography procedure.
Announcing the receipt of approval for single-dose vials (50 mg/5 ml), the company said the product is expected to be launched by March.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Lymphazurin injection, 1%, of Covidien.
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Explaining the use, a release from the company said upon subcutaneous administration, Isosulfan Blue Injection delineates the lymphatic vessels draining the region of injection.
The approved product had an estimated market size of $ 57 million during the twelve months ended December 2015, the company said quoting IMS data.
This is the 24th ANDA to be approved out of the Aurobindo Pharma's Unit IV formulation facility in Hyderabad, used for making general injectable products.
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