Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Meropenem Injection 500 mg/vial and 1 g/vial. The company’s Meropenem 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 3 or more than 3 months only), complicated intra-abdominal infections such as appendicitis and peritonitis (adult patients and pediatric patients 3 or more than 3 months only) and bacterial meningitis (pediatric patients 3 or more than 3 months only). The approved product has an estimated market size of $118 million for the twelve months ending January 2017.
This is the 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 USFDA.