Aurobindo Pharma Limited has received final approval to manufacture and market Esmolol Hydrochloride Injection from the US Food and Drug Administration (USFDA).
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.
It 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 for manufacturing general injectable products and will be marketed and sold by Aurobindo's wholly-owned subsidiary AuroMedics Pharma LLC. The Aurobindo counter closed 0.41 percent up at Rs 738 on the BSE.