American Pharmaceutical Partners, Inc. (APP) announced that its wholly owned subsidiary, Pharmaceutical Partners of Canada (PPC), received Canadian marketing approvals of Piperacillin for Injection, USP, the generic equivalent of Wyeth's Pipracil, and Fluconazole Injection, the generic equivalent of Pfizer's Diflucan Injection.
Piperacillin is a third-generation, antibiotic indicated for the treatment of serious infections caused by designated susceptible microorganisms such as P. aeruginosa commonly referred to as pseudomonas. Piperacillin is active against a variety of gram-positive and gram-negative aerobic and anaerobic bacteria.
Piperacillin will be available from PPC in 2g, 3g, and 4g vials with anticipated launch in the 2004 second quarter.
Fluconazole is indicated for the treatment of oropharyngeal and esophageal candidiasis, certain systemic candidal infections, including urinary tract infection, peritonitis and pneumonia, and cryptococcal meningitis, and will be available in 2mg/mL, packaged in 200mg/100mL and 400mg/200mL single-dose vials. PPC expects to commence marketing fluconazole in the 2004 third quarter.
The company also announced that it expects to launch pamidronate disodium for injection in Canada in early March 2004. Pamidronate disodium is a bone-resorption inhibitor used to treat hypercalcemia associated with malignancy, with bone metastases, and Paget's disease, and is the generic equivalent of Novartis Pharmaceuticals' Aredia.
Combined sales in Canada of these three products was approximately $20 million in 2003.
"We are pleased to offer piperacillin because it addresses an unmet medical need, specifically the medical community's increasing concern over resistance to anti-infectives," said Patrick Soon-Shiong, APP chairman, president and chief executive officer. "These three products complement PPC's growing product offering of more than 36 drug products and moves us closer to our goal of establishing PPC as a leading provider of injectable products in the Canadian market."