Aurobindo Pharma Gets USFDA Approval for Anti-Bacterial Injection

Hyderabad-based Aurobindo Pharma has announced the receipt of final approval from the US Food & Drug Administration (USFDA) to manufacture and market ‘Ertapenem Injection’ 1 g/vial. The injection is a generic equivalent of Merck Sharp & Dohme Corp’s Invanz injection. The company plans to launch the product in next month. The approved product has an estimated market size of $387-mn for the twelve months ending April 2018 according to IQVIA. “Ertapenem injection is used for the treatment of moderate to severe infections caused by susceptible bacteria. Also indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery,” the company said in a press note.

This ANDA is approved out of Auro-next Pharma’s (a wholly owned subsidiary) formulation facility in Bhiwadi used for manufacturing penem injectable products. Aurobindo now has a total of 371 ANDA approvals (338 final approvals including 17 from Aurolife Pharma LLC and 33 tentative appro-vals) from USFDA.