Product News

Published Online: Tuesday, April 1, 2008


bioM?rieux Inc (Durham, NC) recently received 510(k) clearance from the FDA to market VIDAS B?R?A?H?M?S PCT. The test will be used with critically ill patients on their first day of admission to the intensive care unit (ICU) as an aid to assess their risk for progression to severe sepsis and septic shock. bioM?rieux is the first company in the United States to launch an automated test measuring procalcitonin (PCT), a biological marker for bacterial infections. As the progression of severe bacterial infections is affected by how early the patient receives appropriate treatment, measuring PCT levels is valuable in ICUs where sepsis represents a major health challenge. The VIDAS platform is well-suited to emergency situations, with VIDAS B?R?A?H?M?S PCT providing test results in 20 minutes.

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Polymyxin B Sulfate for Injection

APP Pharmaceuticals Inc (Schaumburg, IL) recently received FDA approval for its abbreviated new drug application for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial. The product is the generic equivalent of Bedford Laboratories? Polymyxin B Sulfate. APP?s Polymyxin B Sulfate for Injection is indicated for the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa. It may be used topically or subconjunctivally in the treatment of infections of the eye caused by susceptible strains of the same organism. It also may be indicated in the case of serious infections caused by specific indicated organisms. Polymyxin B Sulfate for Injections is AP-rated, preservative- and latex-free, and bar-coded at the individual unit of use.

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