Abraxis gains expedited appro of generic cefotetan

Abraxis Pharmaceutical Products, the hospital-based business of Abraxis BioScience, says that the US Food and Drug Administration has granted approval for it to market cefotetan disodium for injection, the generic equivalent of AstraZeneca's Cefotan. 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. APP, now the only supplier of this drug, expects to launch this important anti-infective back into the market this month. Based on previous IMS data, cefotetan has market potential in excess of $40.0 million a year.

Marc Singer, assistant professor of surgery at the University of Illinois at Chicago, said: "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."

In 2006, AstraZeneca's Cefotan was withdrawn from the marketplace due to issues with sourcing of raw material, according to Abraxis.