APP Pharma gets US FDA nod to market penicillin G potassium injection USP

APP Pharmaceuticals, Inc, a wholly-owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc, has received approval from the US Food and Drug Administration (FDA) to market penicillin G potassium for injection, USP, in two dosage strengths. Penicillin G is therapeutically equivalent to the reference drug PfizerPen G, which is marketed by the innovator Pfizer, Inc.

APP will package penicillin G in 5 million and 20 million unit single dose vials. APP's Penicillin G is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States were approximately $16.4 million1.