Aurobindo receives FDA approval for ertapenem injection

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EAST WINDSOR, N.J. — Aurobindo Pharma announced that the company has received final approval from the U.S. Food & Drug Administration to manufacture and market ertapenem injection 1 g/vial.

Aurobindo’s ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp’s Invanz Injection. The product will be launched in July 2018.

The approved product has an estimated market size of US$ 387 million 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.


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