Aurobindo Pharma received final approvals from the US Food and Drug Administration (US FDA) to manufacture and market oxacillin for injection USP, packaged in 1g and 2g vials (ANDA 201539) and oxacillin for injection USP 10g/vial pharmacy bulk package (ANDA 201538). The products are ready for launch.
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.
These ANDAs have been approved out of unit XII formulation facility in Hyderabad, India and will be marketed and sold by Aurobindo’s US subsidiary AuroMedics Pharma LLC.
Aurobindo now has a total of 174 ANDA approvals out of total 149 is final approvals including two from Aurolife Pharma LLC and 25 tentative approvals from US FDA.
EP News Bureau – Mumbai
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