Aurobindo Pharma receives US regulatory nod for Acetaminophen injection

On Thursday, Aurobindo Pharma informed that it has received final approval from US Food & Drug Administration (USFDA) to manufacture and market Acetaminophen injection, 1,000 mg/ 100 ml single-dose vial (SDV), which is a generic equivalent of Mallinckrodt’s Ofirmev injection.

The product, which is expected to be launched in December 2020, is indicated for the treatment of mild to moderate pain in adult and pediatric patients of 2 years and older. The injection is also set to treat moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients of 2 years and above along with the reduction of fever in adult & pediatric patients.

According to data from IMS Health, the approved product has an estimated market size of US$ 339 million for the twelve-month ending August 2020. This is the 75th ANDA to be approved out of Unit IV formulation facility in Hyderabad (India), used for manufacturing injectable & ophthalmic products.

The company’s US business is poised to grow in double digits in the quarters ahead due to a combination of factors including studying a new product line, opportunities arising out of shortage of products in the US, and an expected recovery in the injectable business. The latest approval for Acetaminophen injection in the US markets is likely to aid in the revenue growth for the company in the US markets.

On Thursday, the stock of Aurobindo Pharma closed at Rs 782.45 per share, down by 2.84 per cent or Rs 22.85 per share on BSE, against a 0.37 per cent decline in the benchmark index. Its 52-week high is recorded at Rs 967.60 and the 52-week low is Rs 281.15 on BSE.