Drug major Aurobindo Pharma has received final approval from the US health regulator to manufacture and market Atracurium Besylate injections in the American market.
"The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Atracurium Besylate injections, 10 mg/mL, 5 mL single-dose vials and 10 mg/mL, 10 mL multi-dose vials," Aurobindo Pharma said in a statement.
The approved abbreviated new drug applications (ANDAs) are generic versions of Eurohealth International Sarl's Atracurium Besylate injections, it added.
The 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 Pharma said.
At present, the company has 11 ANDAs approved out of its Unit IV formulation facility in Hyderabad, manufacturing general injectable products, it added. Aurobindo Pharma shares were trading 1.07 percent up at Rs 1,337.25 per scrip during afternoon trade on the BSE.
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