New Delhi, Oct 22: Drug firm Aurobindo Pharma on Thursday said it has received final approval from the US health regulator for its generic Acetaminophen injection, used in the treatment of pain in adult and paediatric patients.
The company has received the approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen injection, 1,000 mg/ 100 mL single-dose vial, Aurobindo Pharma said in a BSE filing.
The product will be launched in December 2020, it added.
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.
(PTI)
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