FDA issues marketing approval for APP Pharmaceuticals' Penicillin G potassium for Injection, USP

Aug 25 2009

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ), announced today that it has received approval from the U.S. 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.

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 U.S.”