Tag Archives: Priority Review

Avycaz Approval and Labeling Restrictions

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On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions→

What is the “Niche” for Ceftolozane / Tazobactam?

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There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, and how this all matters in clinical practice, on the Continue reading What is the “Niche” for Ceftolozane / Tazobactam?→