USFDA gives final nod for Aurobindo's Meropenem anti-bacterial injection

It's the first ANDA from firm's Bhiwadi unit to be approved; market size: $118 mn in the US

Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Meropenem injection, which is used in the treatment of complicated skin and other bacterial infections.

Meropenem injection 500 mg/vial and 1 g/vial will be launched next month. This is a generic version of AstraZeneca Pharmaceuticals' Merrem injection. It is indicated as single agent therapy for skin infections, complicated intra-abdominal infections such as appendicitis and peritonitis, and bacterial meningitis, the company said in a statement.

According to IMS, Meropenem has an estimated market size of $118 million for the twelve months ending January 2017. This is the first abbreviated new drug application (ANDA) approved out of its subsidiary Auronext Pharma's formulation facility in Bhiwadi. This unit is used for manufacturing penem injectable products.

With this, the Hyderabad-based company has an overall 314 ANDA approvals including 16 from Aurolife Pharma and 39 tentative approvals from the USFDA.