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 million.

Penicillin G is used to treat a wide variety of bacterial infections, including pneumococcal infections, streptococcal infections, staphylococcal infections, diphtheria, meningitis, clostridial infections and anthrax. According to the Centers for Disease Control and Prevention (CDC), Penicillin G is the treatment of choice for congenital syphilis, neurosyphilis and prophylaxis of intrapartum group B streptococcus.

"The addition of Penicillin G further strengthens APP's broad anti-infective portfolio," said Thomas H Silberg, president and chief executive officer of APP Pharmaceuticals. "We are looking forward to making this potentially life-saving antibiotic available to patients throughout the US."

APP Pharma is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anaesthetic/analgesic and critical care markets.

Fresenius Kabi AG is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific.