Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen Injection, 1,000 mg/ 100 mL single-dose vial (SDV). Aurobindo’s Acetaminophen Injection is a generic equivalent of Mallinckrodt’s Ofirmev Injection. The product will be launched in December 2020.
Acetaminophen Injection is indicated for the treatment of mild to moderate pain in adult and paediatric patients two years and older. The injection is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and paediatric patients two years and older, and reduction of fever in adult and paediatric patients.
The approved product has an estimated market size of $339 million for the twelve months ending August 2020 according to IQVIA. This is the 75th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing injectable and ophthalmic products.
Aurobindo now has a total of 449 ANDA approvals (421 Final approvals and 28 tentative approvals) from USFDA.