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Aurobindo Pharma gets final approval from USFDA to market anaesthesia drug

The approved product is a generic equivalent of Organon's Norcuron Injection

Press Trust of India  |  New Delhi 

Aurobindo Pharma

on Monday said it has received final approval from the US health regulator to market anaesthesia drug Injection.

The company has received final approval from the (USFDA) to manufacture and market Injection in the strengths of 10mg and 20mg, said in a BSE filing.

The approved product is a generic equivalent of Organon's

said the product, used as part of general anesthesia to provide skeletal muscle during surgery or mechanical ventilation, will be launched in the last quarter of fiscal 2018-19. Injection is also used to facilitate endotracheal intubation.

Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of $11 million for the 12 months ending September 2018.

This is the 58th abbreviated new drug application (ANDA) to be approved out of unit IV formulation facility in Hyderabad used for manufacturing general injectable and ophthalmic products, the company said.
 

Aurobindo now has a total of 397 ANDA approvals (369 final approvals including 20 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Stock of Aurobindo Pharma was trading 0.10 per cent higher at Rs 719.85 apiece on BSE.

First Published: Mon, December 24 2018. 11:21 IST
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