Aurobindo Pharma receives US FDA approval

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Atracurium Besylate injections are indicated as an adjunct to general anaesthesia

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to manufacture and market Atracurium Besylate injection, 10mg/mL, 5mL single-dose vials (ANDA 206010) and 10mg/mL, 10mL multi-dose vials (ANDA 206011).

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 eight 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.

ANDAAtracurium BesylateAurobindo PharmaAuroMedics PharmaUS FDA