April Product News
VIDAS B?R?A?H?M?S PCT
bioM?rieux Inc(Durham, NC) recentlyreceived 510(k)clearance from theFDA to market VIDASB?R?A?H?M?S PCT. Thetest will be usedwith critically ill patientson their firstday of admission tothe intensive careunit (ICU) as an aid to assess their risk for progression to severesepsis and septic shock. bioM?rieux is the first company in theUnited States to launch an automated test measuring procalcitonin(PCT), a biological marker for bacterial infections. As theprogression of severe bacterial infections is affected by howearly the patient receives appropriate treatment, measuringPCT levels is valuable in ICUs where sepsis represents a majorhealth challenge. The VIDAS platform is well-suited to emergencysituations, with VIDAS B?R?A?H?M?S PCT providing testresults in 20 minutes.
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Polymyxin B Sulfate for Injection
APP Pharmaceuticals Inc(Schaumburg, IL) recently receivedFDA approval for its abbreviatednew drug application for PolymyxinB Sulfate for Injection, USP, 500,000units/vial. The product is the genericequivalent of Bedford Laboratories?Polymyxin B Sulfate. APP?sPolymyxin B Sulfate for Injection isindicated for the treatment ofacute infections caused by susceptiblestrains of Pseudomonasaeruginosa. It may be used topicallyor subconjunctivally in the treatmentof infections of the eye caused by susceptible strains of thesame organism. It also may be indicated in the case of seriousinfections caused by specific indicated organisms. Polymyxin BSulfate for Injections is AP-rated, preservative- and latex-free,and bar-coded at the individual unit of use.
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