The product will be launched in Q4FY19
Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Vecuronium Bromide Injection, 10mg and 20mg. Aurobindo’s Vecuronium Bromide Injection is a generic equivalent of Organon’s Norcuron Injection. The product will be launched in Q4FY19. Vecuronium Bromide Injection is used as part of general anesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also used to facilitate endotracheal intubation.
The approved product has an estimated market size of $11 million for the twelve months ending September 2018 according to IQVIA. This is the 58th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable & ophthalmic products.
Aurobindo now has a total of 397 ANDA approvals (369 Final approvals including 20 from Aurolife Pharma C and 28 tentative approvals) from US FDA.