Hyderabad-based Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Nafcillin injections.
The drug is a sterile semi synthetic penicillin indicated in the treatment of infections caused by penicillinase-producing staphylococci bacteria, according to a press release issued here today.
The USFDA approval include two abbreviated new drug applications (ANDAs) for injections packaged in 1 gram and 2 gram vials and for 10 gram/vial pharmacy bulk package, it said.
The products have been approved out of its unit eleven formulation facility in Hyderabad and will be marketed and sold by the company's US subsidiary AuroMedics Pharma LLC. The products are ready for launch, the company said.
According to some reports, Nafcillin injections had an annual market of about $62 million in the US, till September, 2012.
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