It is a generic version of Mallinckrodt's Ofirmev injection.
According to IQVIA data, the approved product has an estimated market size of USD 339 million for the twelve months ending August 2020, Aurobindo Pharma said.
Acetaminophen Injection is indicated for the treatment of mild to moderate pain in adult and paediatric patients 2 years and older. It is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and paediatric patients 2 years and older, and reduction of fever, the company noted.
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,it added.
The company now has a total of 449 ANDA approvals (421 final approvals and 28 tentative approvals) from the USFDA, Aurobindo Pharma said.
Shares of Aurobindo Pharma were trading at Rs779.35per scrip on BSE, down 3.22 per cent from its previous close.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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