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Aurobindo Pharma Limited today announced that the company has received final approvals from the US Food and Drug Administration(USFDA) to manufacture and market Esmolol Hydrochloride Injection 100 mg/10 ml.
The injection is bioequivalent and therapeutically equivalent to the reference listed drug product Brevibloc of Baxter Healthcare Corporation. Esmolol Hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occurs during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, according to Aurobindo.
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 and will be marketed and sold by Aurobindo's wholly owned subsidiary AuroMedics Pharma LLC, it said.
