Aurobindo PharmaNSE -0.30 % Monday said it has received final approval from the US health regulator to market anaesthesia drug Vecuronium Bromide Injection.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vecuronium Bromide Injection in the strengths of 10mg and 20mg, Aurobindo Pharma said in a BSE filing.
The approved product is a generic equivalent of Organon’s Norcuron Injection.
Aurobindo Pharma said the product, used as part of general anesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation, will be launched in the last quarter of fiscal 2018-19. Vecuronium Bromide Injection is also used to facilitate endotracheal intubation.
Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 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.