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Aurobindo Pharma gets USFDA nod for Isosulfan Blue injection

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Announcing the receipt of approval for single-dose vials (50 mg/5 ml), the company said that the product was expected to be launched by March.

Aurobindo Pharma Ltd. on Wednesday said it has received final approval from the US 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 that the product was 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.

Explaining the use, a release from the company said that 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 12 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 manufacturing general injectable products.

Interim dividend

In another announcement, the company said that the Board of Directors meet scheduled on February 9 will consider the proposal of payment of third interim dividend for 2015-16 besides the results for the quarter ended December 2015 (Q3).

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Printable version | Dec 7, 2019 6:43:07 AM | https://www.thehindu.com/business/aurobindo-pharma-gets-usfda-nod-for-isosulfan-blue-injection/article8188084.ece

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