Aurobindo Pharma receives USFDA Approval for Acetaminophen Injection

Aurobindo Pharma Limited 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 pediatric patients 2 years and older. The injection is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older, and reduction of fever in adult and pediatric patients. The approved product has an estimated market size of US$ 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 & ophthalmic products. Aurobindo now has a total of 449 ANDA approvals (421 Final approvals and 28 tentative approvals) from USFDA.

Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.805.6 as compared to the previous close of Rs. 800.2. The total number of shares traded during the day was 82119 in over 2112 trades.

The stock hit an intraday high of Rs. 808.6 and intraday low of 792. The net turnover during the day was Rs. 65955222.

Source : Equity Bulls

Keywords