Aurobindo Pharma gets USFDA’s nod for Oxacillin Injections

Aurobindo Pharma Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 524804 | NSE: AUROPHARMA

21 Jan 2013 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Oxacillin for Injection USP, packaged in 1g and 2g vials and Oxacillin for Injection USP 10g/Vial Pharmacy Bulk Package. The products are ready for launch.

These ANDAs have been approved out of Unit XII formulation facility in Hyderabad, India and will be marketed and sold by the company’s US subsidiary AuroMedics Pharma LLC.

Oxacillin for Injection USP is a sterile semisynthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.

Aurobindo now has a total of 174 ANDA approvals (149 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

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