Aurobindo Pharma gets USFDA nod for Nafcillin injections

Drug firm Aurobindo Pharma said it has received final approval by the US health regulator to manufacture and market Nafcillin for injection used for treating bacterial infections in the American market. The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Nafcillin for injection USP, packaged in 1g and 2g vials and Nafcillin for injection USP 10g/vial pharmacy bulk package, Aurobindo Pharma said in a statement.

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"The products are ready for launch," it added. These abbreviated new drug applications (ANDAs) have been approved out of the company's unit XII formulation facility in Hyderabad and will be marketed and sold by its US subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said. The company currently has a total of 171 ANDA approvals (145 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals), it added.

"Nafcillin for injection is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug," the company said. Shares of Aurobindo Pharma were trading at Rs 192.40 per scrip on BSE, down 0.31 per cent from its previous close.