Aurobindo Pharma has received final approval from US FDA to manufacture and market meropenem injection 500 mg/vial and 1g/vial. This injection is a generic equivalent of AstraZeneca Pharmaceuticals' Merrem injection. The product will be launched in April 2017.
Meropenem injection is indicated as single agent therapy for the treatment of complicated skin and skin structure infections (adult patients and pediatric patients), complicated intra-abdominal infections such as appendicitis and peritonitis and bacterial meningitis. The approved product has an estimated market size of US$ 118 million for the twelve months ending January 2017 according to IMS.
This is first ANDA approved out of Auronext Pharma's (wholly owned subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 314 ANDA approvals (275 final approvals including 16 from Aurolife Pharma LLC and 39 tentative approvals) from US FDA.