New Delhi : Drug firm Aurobindo Pharma has received final approval from the US health regulator for Meropenem injection used for treatment of complicated skin and related infections, complicated intra abdominal infections and bacterial meningitis.
The company “has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem injection 500 mg/vial and 1g/ vial,” Aurobindo Pharma said in a filing to BSE.
This is a generic version of AstraZeneca Pharmaceuticals’ Merrem injection, it added.
“The approved product has an estimated market size of USD 118 million for the 12-month ending January 2017, according to IMS,” said Aurobindo Pharma.
This is the first ANDA (Abbreviated New Drug Application) approved out of Auronext Pharma facility in Bhaiwadi used for manufacturing penem injectable products.
Auronext Pharma is a wholly-owned subsidiary of Aurobindo Pharma.
With this, Aurobindo now has a total of 314 ANDA approvals.