FDA approves APP Pharmaceuticals' Piperacillin and Tazobactam for Injection

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Piperacillin and Tazobactam for Injection, the number one prescribed intravenous antibiotic in the U.S. APP will launch the product immediately.

Piperacillin and Tazobactam for Injection is therapeutically equivalent to the reference-listed drug Zosyn^®, which is marketed by Pfizer Injectables. According to IMS data, 2010 sales of the branded product in the United States were approximately $750 million. Piperacillin and Tazobactam is a broad spectrum injectable antibiotic with a range of activity against gram-positive and gram-negative aerobic and anaerobic organisms.

"APP's approval of the number one prescribed injectable anti-infective enables us to continue our commitment of bringing affordable medications to hospitals, clinics and long-term care facilities throughout the U.S.," said John Ducker, President and Chief Executive Officer of APP Pharmaceuticals. "This approval further expands one of the most comprehensive and cost-effective portfolios of anti-infective injectable products in the industry."  

Source: APP Pharmaceuticals, Inc