APP Pharmaceuticals Receives Approval For Penicillin G Potassium For Injection, USP

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Aug 2009 - 17:00 PDT

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ), announced 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."

About APP Pharmaceuticals, Inc.

APP Pharmaceuticals, Inc. is a fully-integrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, anti-infective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, long-term care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the company's Web site at http://www.APPpharma.com.

1 2008 IMS Data

Source
Fresenius Kabi AG

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