American Pharmaceutical Partners Inc has received NDA approval from the US FDA to launch Tobramycin for Injection, USP for the treatment of septicemia, lower respiratory tract infections, serious central nervous system infections, intra-abdominal infections, skin, bone, and skin structure infections, and complicated and recurrent urinary tract infections, a company release said.

This represents the company's first 505(b)(2) NDA approval and is the only free flowing Tobramycin powder for injection that is consistent with the innovator product Nebcin, which, according to the American Society of Hospital Pharmacists, was discontinued by Eli Lilly in 2002 for reasons other than safety. According to IMS, sales for Nebcin (Tobramycin for injection) reached $34 million in 2001 before becoming unavailable in 2002, the release says.

"The product that I most commonly use in the place of Nebcin is a lyophilized cake that can be difficult to get out of the bottle and mix due to clumping," said William A Jiranek, chief of Adult Reconstruction, Department of Orthopaedic Surgery, Virginia Commonwealth University Medical Centre, Richmond, VA. He added, "Unfortunately, these product characteristics can adversely affect the desired result."

"In order to attain the product attributes needed in the market, we had to rethink the way we developed the product. Our Tobramycin goes through a series of complex manufacturing steps in order to achieve the necessary consistency," said Patrick Soon-Shiong, APP's chairman, president and chief executive officer. "As a result, APP's Tobramycin will be available as a Free Flowing lyophilized powder," he continued.

"With this approval of the only free flowing Tobramycin for injection, we are realizing an important facet of APP's development strategy which strives to address unmet market needs and enhance the safety of patient and hospital administration staff. For example, APP was the first to initiate bar coding which can help reduce medication errors, the first to launch Steri-Tamp which is designed to enhance patient safety, and the only manufacturer to supply piperacillin and dimenhydrinate, both addressing hospital needs," he added.

In addition to providing a lyophilized powder that produces an easily-mixable formulation, APP is packaging Tobramycin with a tear cap to offer users an easier-to-open alternative to the standard flip cap. Tobramycin will be available in a 1.2g vial. The approval of Tobramycin for injection establishes APP as the only company offering hospital pharmacists a full line of lyophilized and liquid formulations of Tobramycin. In addition to the 1.2g vial of Tobramycin for injection, APP also manufactures four liquid formulations: 10mg/ml 2ml paediatric; 40mg/ml 2ml; 40mg/ml 30ml and 40mg/mL 50mL PBP.

American Pharmaceutical Partners Inc is a drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.