Aurobindo Pharma receives US FDA approval for Esmolol Hydrochloride injection

Esmolol Hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Esmolol Hydrochloride injection, 100mg/10mL (10mg/mL), (ANDA 205520).

Esmolol Hydrochloride injection, 100mg/10mL (10mg/mL) is bioequivalent and therapeutically
equivalent to the reference listed drug product (RLD) Brevibloc injection, 10mg/mL of Baxter Healthcare Corporation. Esmolol Hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period.

Aurobindo now has 13 ANDAs (represented by 10 product classes) approved out of Unit IV
formulation facility in Hyderabad, India for manufacturing general injectable products marketed and sold by Aurobindo’s wholly-owned subsidiary AuroMedics Pharma.