Pharmaceutical company Aurobindo Pharma Limited is pleased to announce that the company has obtained 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, Aurobindo Pharma said. 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 2 years and older, and reduction of fever in adult and paediatric patients.
The approved product has an estimated market size of USD 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 ie, (421 Final approvals and 28 tentative approvals from USFDA.
Aurobindo Pharma Stock watch at mid-session: During the mid-session (at around 1.25-pm) of trade in the stock market, share price of Aurobindo Pharma was quoting at Rs.776.45, down by Rs.29.75 or 3.69 percent from its previous closing of Rs.806.20 on the National Stock Exchange. The stock opened at Rs807 and has touched a high and low of Rs807 and Rs749.20 respectively.
