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Aurobindo Pharma Ltd has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Atracurium Besylate Injection, 10mg/mL, 5mL single-dose vials and 10mg/mL, 10mL multi-dose vials.
The two abbreviated new drug applications (ANDAs) approved are bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Atracurium Besylate Injections USP of Eurohealth International Sarl.
Atracurium Besylate Injections are indicated as an adjunct to general anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, according to a press release from the Hyderabad-based pharma major.
Aurobindo now has 11 ANDAs (represented by eight product classes) approved out of its 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.
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