FDA approves Abraxis’s cefotetan disodium for injection

Abraxis Pharmaceutical Products (APP) claims that cefotetan has the longest half-life of any first- or second-generation cephalosporin and offers surgeons a convenient single-dose option for surgical prophylaxis and secondary infections.

The company expects to launch this anti-infective during August. Based on previous IMS data, Cefotetan has market potential in excess of $40 million.

“Access to this drug will help surgeons prevent post-operative infections, which, if not successfully prevented, can have serious consequences resulting in illness or even death,” said Marc Singer, assistant professor of surgery at the University of Illinois at Chicago.

“In addition, compliance with perioperative antibiotic administration has become a strictly monitored quality assurance measure. With Cefotetan, we may not need to re-dose in the operating room which will ultimately help to improve both patient safety and compliance,” he continued.

In 2006, AstraZeneca’s Cefotan was withdrawn from the marketplace due to issues with sourcing of raw material.

“We have secured a new, alternate raw material supplier versus the company previously utilized by the innovator and are confident in their experience in cephalosporin raw material manufacturing and ability to provide consistent supply,” said Thomas Silberg, president of APP.

As a second-generation cephalosporin, Cefotetan is administered prior to surgery to help prevent surgical prophylaxis and secondary infection following certain abdominal and gynecological procedures such as colorectal surgery, vaginal or abdominal hysterectomies and cesarean sections.

Cefotetan is also indicated for treating and preventing infections elsewhere in the body that are proven or strongly suspected to be caused by susceptible bacteria, including urinary tract infections, lower respiratory tract infections, skin and skin structure infections, gynecologic infections, intra-abdominal infections and bone and joint infections.