FDA gives nod to Aurobindo Pharma 's Esomol Hydrochloride Injection
USFDA has given a green signal to Aurobindo Pharma manufacture and market Esmolol Hydrochloride Injection for the short-term treatment of tachycardia and hypertension
Aurobindo Pharma has received an approval from the US Food and Drug Administration to manufacture and market Esmolol Hydrochloride Injection. The treatment through the injection 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.
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.
Aurobindo pharma 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.