Aurobindo Pharma has received final approvals from the US FDA to manufacture and market Nafcillin for injection USP, packaged in 1g and 2g vials (ANDA 091613) and Nafcillin for injection USP 10g/vial pharmacy bulk package (ANDA 091614). The products are ready for launch.
Nafcillin for injection is a sterile semisynthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. It may be used to initiate therapy in suspected cases of resistant staphylococca infections prior to the availability of susceptibility test results. 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 171 ANDA approvals (145 final approvals including 2 from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.