 "Aurobindo Pharma receives USFDA nod for anaesthesia drug")
Aurobindo Pharma Limited has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market atracurium besylate injection, 10 mg/mL, 5 mL single-dose vials and 10 mg/mL, 10 mL multi-dose vials.
The approved ANDAs 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.
Aurobindo now has 11 ANDAs (represented by 8 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 approved ANDAs 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.
Aurobindo now has 11 ANDAs (represented by 8 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.