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FDA Approves Pfizer’s Eraxis

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer has received approval from the FDA for Eraxis to treat candidemia, a potentially life-threatening bloodstream infection. Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of approximately 40%.

In clinical studies, Eraxis was as well tolerated and the total number of drug-related adverse events was comparable to fluconazole. Eraxis has not been associated with renal toxicity and has no clinically relevant drug-to-drug interactions. Eraxis also does not require dose adjustments based on gender, race, age, HIV status, hepatic insufficiency or renal insufficiency. Eraxis is the only medicine that has demonstrated improved efficacy versus fluconazole in a pivotal clinical trial for the treatment of candidemia.

Eraxis was also approved by the FDA to treat intra-abdominal abscesses and esophageal candidiasis.

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