New Delhi: Drug firm Aurobindo Pharma today said it has received final approvals from the US health regulator to manufacture and market Oxacillin for Injection used for treating bacterial infections in the American market.
The company has received final approvals 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, Aurobindo Pharma said in a statement. The products are ready for launch, it added.
These abbreviated new drug applications (ANDAs) have been approved out of the company’s facility in Hyderabad and will be marketed and sold by its US subsidiary AuroMedics Pharma LLC, Aurobindo Pharma said.
“Oxacillin for Injection USP is a sterile semi-synthetic penicillin (SSP) indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug,” it added.
Aurobindo now has a total of 174 ANDA approvals, the company said. Shares of Aurobindo Pharma were today trading at Rs 195.55 apiece in the afternoon trade on BSE, up 1.53 percent from their previous close.