Aurobindo gets USFDA nod for Esomol Hydrochloride Injection

City-based Aurobindo Pharma Limited today said it has received final approvals from the US Food and Drug Administration (USFDA) to manufacture and market Esmolol Hydrochloride Injection.
According to a press release, 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 anaesthesia and in the postoperative period, it said.
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 statement added.

The Aurobindo counter closed 0.41 per cent up at Rs 738 on the BSE.