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Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic Acetaminophen injection. It is indicated in the treatment of pain in adult and paediatric patients.
The Hyderabad-based company can now manufacture and market the product which is a generic version of Mallinckrodt’s Ofirmev injection. The product will be launched in December, Aurobindo informed the BSE.
According to IQVIA data, the approved product has an estimated market size of $339 million for the twelve months ending August 2020, Aurobindo Pharma said.
This is the 75th abbreviated new drug application (ANDA) to be approved out of the Unit IV formulation facility in Hyderabad, used for manufacturing injectable and ophthalmic products, the company said.
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