American Pharmaceutical Partners, Inc (APP) has received approval from the US FDA to launch a 40g vial of Piperacillin for Injection, USP, the generic equivalent of Wyeth's Pipracil. The 40g vial joins APP's current offering of Piperacillin for Injection in 2g, 3g, and 4g single-dose vials, a company release said.

"When APP launched generic Piperacillin earlier this year, it provided hospitals and pharmacies with a more targeted anti-infective, which helps to address our concerns over increased resistance," said William P Lane, RPh., sterile products coordinator, Department of Pharmacy Services, University of Pennsylvania Health System, Philadelphia. "The introduction of a 40g vial of Piperacilllin in a pharmacy bulk pack is great news, as it allows for a much more efficient and cost effective preparation process," he added.

Piperacillin is a third-generation, antibiotic indicated for the treatment of serious infections caused by designated susceptible micro-organisms such as aeruginosa commonly referred to as pseudomonas. Piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria.

"With the launch of the 40g vial, we hope to provide hospital pharmacists with a formulation that allows for more controlled and cost effective preparation," said Patrick Soon-Shiong, APP chairman, president and chief executive officer. He added, "We are committed to providing hospital pharmacists with a broad array of quality anti-infectives that not only satisfies treatment, but also helps hospitals be more effective in delivering patient care."

After FDA granted approval earlier this year, APP became the sole provider of Piperacillin for Injection. When Wyeth ceased manufacturing Pipracil in 2002, it created an unmet need requiring hospitals to switch to alternative anti-infectives such as Wyeth's Zosyn, a broader spectrum anti-infective that is a combination of piperacillin and tazobactam.

"Knowing that resistance to anti-infectives is reaching a critical level and is only compounded by the overuse of anti-infectives, APP is pleased to have brought to the market a more targeted anti-infective alternative," said Dr. Soon-Shiong.

Piperacillin for injection is indicated for treatment of serious infections caused by susceptible strains of certain designated micro-organisms found in a variety of conditions including, intra-abdominal infections, urinary tract infections, gynecologic infections, Septicimia, lower respiratory tract infections, skin and skin structure infections, bone and joint infections and uncomplicated gonoccocal urethritis.